Effect of Miswak versus standard preventive measures for caries control of young Egyptian adults: A randomized controlled clinical trial

Rania Rashad Taha; Elham Mostafa Fawzi; Shereen Hafez Ibrahim

doi:10.4103/jioh.jioh_359_21

ORIGINAL RESEARCH

Year : 2022 | Volume : 14 | Issue : 3 | Page : 230-242

Effect of Miswak versus standard preventive measures for caries control of young Egyptian adults: A randomized controlled clinical trial

Rania Rashad Taha¹, Elham Mostafa Fawzi², Shereen Hafez Ibrahim²
¹ Faculty of Dentistry, 6 October University, Cairo, Egypt
² Faculty of Dentistry, Cairo University, Cairo, Egypt

Date of Submission	30-Dec-2021
Date of Decision	19-Apr-2022
Date of Acceptance	20-Apr-2022
Date of Web Publication	28-Jun-2022

Correspondence Address:
Prof. Shereen Hafez Ibrahim
Faculty of Dentistry, Cairo University, 11 EL-Saraya St. Manial, Cairo
Egypt

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/jioh.jioh_359_21

Abstract

Aim: To evaluate the effectiveness of Miswak in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients. Materials and Methods: In this randomized control clinical trial, 26 participants per group of dental students aged from 18 to 25 years were recruited with high caries risk based on sample size calculation. The DMF score was determined. Plaque index was recorded at baseline and after 1 year. Participants were randomized into one control group and two intervention groups. The control group (Group 1) used the standard oral hygiene measures. Group 2 used Miswak only, whereas Group 3 used Miswak plus toothbrush and toothpaste. Data were collected and statistically analyzed with the significance level set at P ≤ 0.05 within all tests. Results: Caries risk assessment revealed that at baseline, there was no statistically significant difference in plaque index score distribution between the different study groups (P = 0.532). At baseline, there was no statistically significant difference in DMF counts distribution between the different study groups (P = 0.268 in D counts, and P = 0.268 in F counts). There were no new lesions detected in all groups at different evaluation times. Conclusions: Using Miswak as a natural product solely is as effective and safe as using the standard oral hygiene measures combined. The use of a time-saving preventive regimen could be promising for the compliance of the high caries risk population.

Keywords: Interdental Cleaning, Miswak, Mouth Wash, Tooth Brush, Tooth Paste

How to cite this article:
Taha RR, Fawzi EM, Ibrahim SH. Effect of Miswak versus standard preventive measures for caries control of young Egyptian adults: A randomized controlled clinical trial. J Int Oral Health 2022;14:230-42

How to cite this URL:
Taha RR, Fawzi EM, Ibrahim SH. Effect of Miswak versus standard preventive measures for caries control of young Egyptian adults: A randomized controlled clinical trial. J Int Oral Health [serial online] 2022 [cited 2023 Sep 22];14:230-42. Available from: https://www.jioh.org/text.asp?2022/14/3/230/348422

Introduction

Caries affecting teeth is one of the most widespread problems in public health worldwide. It is a disease that is considered multifactorial and affected by many variables such as the patient’s general health, oral hygiene measures, type and amount of diet, type of flora of the oral cavity, and factors present in the saliva and fluoride exposure.^[1],[2]

Caries has been combated using various products, and strategies. However, standard care is always recommended by using tooth brushing on a regular basis, interdental cleaning, and mouthwashes/rinses containing chlorhexidine and fluorides in order to control the microbiome and allow remineralization. The latter procedures take a certain amount of time, effort, and cost. In certain cases of high caries risk, a clinic setting of costly adjunct preventive regimen is recommended such as the use of fluoride varnishes.^[3]

The patient compliance to use the multiple regular oral hygiene preventive tools might be an obstacle to achieve optimum oral health conditions. Hence, combining these tools together in one tool could be a solution to motivate patients. Natural products such as Miswak chewing sticks are among the preventive oral hygiene tools that could be used for mechanical and chemical control at the same time.^[4] They are used due to their reduced toxicity, availability, and cost-effectiveness. Miswak belongs to the Salvadoraceae family (Salvadora persica tree as arāk, in Arabic) and is a cleaning twig that serves as a natural toothbrush impregnated with special remedial components that have several benefits being anticaries, antiplaque, anti-fungal, and anti-periopathic.^[5],[6] Miswak has been used over 7000 years ago and was emphasized and recommended in Islamic culture to be used as part of daily routine general and oral hygiene.^[5],[7] Miswak stick is naturally available, having different diameters (from 1 to 1.5 cm), inexpensive, effective, and has other marked beneficial properties. It is generally found in Central Asia, Southeast Asia, the Indian subcontinent, North Africa, the Horn of Africa, the Arabian Peninsula parts of the Sahel, and is predominant in areas inhabited by Moslems.^[8]

On the contrary, toothbrushes and toothpastes are available in various forms and are used in conjunction with chemotherapeutic containing mouth rinses such as Chlorhexidine (CHX) that are used to target the plaque effectively and reduce the level of oral Streptococcus mutans.^[9],[10]

A recent systematic review held by Langa et al.^[11] revealed that cetylpyrydinium chloride (CPC) containing mouth rinse is efficacious in plaque and gingival inflammatory parameters.

As for the fluoride rinses, a systematic review carried out by Marinho et al.^[12] evaluated the use of fluoride mouth rinses as a caries-preventive intervention over 37 trials involving children and adolescents revealed that the regular use of fluoride mouth rinse is associated with a large reduction in caries increment in permanent teeth.

However, in certain circumstances, patients still develop new carious lesions. This could be due to the fact that the supportive oral health aids and chemotherapeutic products are generally costly and many steps are required which might affect patient compliance. A recent trend is rising to popularity by using products to minimize time, effort, and side effects. Miswak sticks are commonly being used by many people who are culturally accustomed to using them.^[6]

Reviving the use of Miswak could be a solution due to the zero chemical formulation and the presence of about 19 active ingredients like alkaloids as antimicrobial, silica to remove the stains, calcium, chloride, fluoride, sulfur, vitamin C for the gums, resins as a protective layer to the enamel, tannins as natural astringent to stimulate the saliva, saponins, flavonoids, and sterols as well as essential oils that stimulate the production of saliva and imparts a mild taste and fragrance.^[13]

From all of the available data, Miswak wicks could help in appropriate tooth cleaning, interdental cleaning, and provision of needed minerals to minimize caries risk and prevent the disease.^[13] The objective of this study was to conduct an randomized clinical trial (RCT) to evaluate the effectiveness of miswak in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients. Thus, the alternative hypothesis tested was that using miswak will show a significant difference over using standard preventive measures in high caries risk patients. One single natural product can replace chemical and chemo-mechanical methods.

Materials and Methods

Trial ethical approval and registration

The study was then approved by the Ethical Committee, Faculty of Dentistry, Cairo University (number18943) on 26-9-2018 and registered on the clinical trial.gov (registration ID: NCT03732040) in September 2018.

Recruitment and informed consent

The trial was run between November 2019 and January 2021. The participants were recruited from the dental students of the Conservative Dentistry Department, Faculty of Dentistry at 6 October University, Cairo, Egypt after explaining the procedures of the trial. Screening was done for 100 students and participants fulfilling the eligibility criteria were enrolled until the target population with high caries risk was achieved to reach a total of 78 participants. Fourteen participants did not fulfill the eligibility criteria and 8 participants refused to enroll. The characteristics of selection according to Featherstone et al.^[14] caries risk assessment form were in terms of inclusion /exclusion criteria and caries experience, presence of active lesions in the last 6 months or frequency of cariogenic diet and number of restorations. Each patient signed a consent form in Arabic denoting the full knowledge about the trial. A flow chart of the study timeline and the steps involved in this clinical trial was presented in [Figure 1].

Figure 1: Flow chart

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Eligibility criteria for participants

The inclusion criteria for participants were no medical illness, males or females, 18–25 years old with high caries risk. Exclusion criteria for participants were patients on antibiotic therapy or corticosteroid therapy for 30 days prior to the examination to avoid any disturbance of microflora balance or development of drug-induced lesion. History of professional cleaning within the past 15 days. Patients with exposed pulp, periapical abscess or fistula as they will be under medication and patients in pain who will avoid eating on a side to avoid a confounder in the study outcome. Evidence of parafunctional habits was also excluded as they could be destructive forces and teeth may be susceptible to caries due to bruxism or cracks that will affect the study outcome patients having developmental dental anomalies, patients experiencing or will begin orthodontic treatment, with appliances or patients with a removable prosthesis as they will be difficult in dental cleaning

Study setting

The protocol of the study was designed following the SPIRIT 2013 Statement and approved by the Conservative Dentistry Committee and internal Evidence-based Dentistry committee (EBD) – Faculty of Dentistry, Cairo University. The research was written following the CONSORT guidelines C52 to ensure transparent and complete reporting.

Trial design

It is a RCT, with parallel-arm design, two-tailed test superiority frame aiming to test the superiority of Miswak with an allocation ratio: 1:1:1.

The following preventive measures materials were used in this study. All materials’ descriptions, lot numbers, and manufacturers are listed in [Table 1].

Table 1: Materials descriptions, lot number, and manufacturers

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Miswak: (Swak Alṣifa, Pakistan).

Tooth Paste: Signal (Cavity Fighter), Unilever Mashreq, Egypt,

Tooth Brush: Oral B, Ireland,

Waxed Dental Floss: Fuchs, Egypt,

Mouth Wash: Hexitol mouth wash solution, Arab drug company, Egypt,

Mouth rinse: Ezafluor, Panax Pharma from Multi Pharma Co Egypt.

Sample size calculation

According to a previous study by Zhang et al.,^[15] the difference in caries development among at least two groups is 40% via the use of power 80% and 5% significance level; twenty-two participants were required in every group. The number was increased to a sample size of 26 per group to compensate for losses throughout the follow-up. Sample size calculation was attained by Power and sample size PS calculation software version 3.1.2 (Vanderbilt University, Nashville, Tennessee). The total number of participants required was 78.

Caries risk assessment for inclusion of participants

A caries risk assessment form denoted by Featherstone^[14] was used for each recruited participant to outline the disease indicators in terms of visible cavities, white spots on smooth surfaces and restorations in the last 3 years. The risk factors in terms of biological predisposing factors as presence of heavy plaque, type, and frequency of diet and snacks intake, deep pits and fissures, and the protective factors were recorded such as frequent use of fluoride-containing toothpaste or mouth rinse per day, fluoride varnish, xylitol gums, and calcium and phosphate-containing toothpaste. No radiographs were taken, no bacterial tests were performed, and no salivary tests were attempted as all the latter items were not included in the scope of the study.

A pretrial survey was attempted in order to identify how many times do the participants brush their teeth, use interdental cleaning, and mouthwashes/mouth rinses. Although the participants in this study were dental students, educational and dental awareness sessions were given to them describing the importance of the type and frequency of diet and their impact on caries incidence.

Plaque score assessment

The plaque amount was checked and assessed via a disclosing agent (Garnet Disclosing agent, USA), a diagnostic mirror, and a graduated periodontal probe to evaluate the amount of plaque at the level of the cervical part of the teeth. Participants’ plaque score was calculated and recorded by Plaque Index (PI) [Table 2]. Four sites on each tooth were recorded, buccal, lingual, and proximal surfaces.

Table 2: Plaque score assessment

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The plaque score was registered before and after the trial. The Index for the four surfaces was calculated and split by 4 to give the index for the tooth. Six teeth according to the FDI nomenclature: 16, 12, 24 and 36, 32, 44 were used. For example, for a tooth with the following scores on the four surfaces Buccal 2, Lingual 1, Mesial 1, and Distal 2, the Plaque Index will be = (2 + 1+1 + 2) / 4 = 1.5. The index for the patient is obtained by summing the indices for all six teeth and dividing by six. Participant’s plaque score was entered in the Cariogram software as shown in [Table 3].

Table 3: Plaque amount score^[16]

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Patient’s preparation

Intraoral photography

Each patient was photographed using Canon 6D-Sigma 105 mm macro lens camera to record frontal, occlusal, and lateral views. Data were stored in a secure digital file.

Professional prophylaxis

Each eligible participant underwent supragingival and subgingival scaling teeth were polished using Prophy mint prophylaxis paste.

Clinical assessment and DMF record

Dental charting was then performed. All data related to the personal information, medical history, dental history, and chief complaint were recorded. Visual examination was done to spot and record the carious lesions in accordance with the World Health Organization (WHO) guidelines via the CPI Probe.^[17] The threshold used was detection of decayed teeth specified to be any visually detected caries lesion including noncavitated lesions. DMF count was performed in order to identify decayed, missed, and filled teeth. The DMF score was then recorded as baseline data.

Caries treatment

A total of 221 carious cavities were found in the 78 participants with an average of 1–3 cavities for each participant. The cavities were prepared using a minimal intervention approach and restored using light-cured resin composite (GrandioSo, Voco, GmbH).

Grouping

The eligible participants were randomly allocated using random allocation software, www.Sealedenvelope.com into three groups (n = 26). Group I represented the positive control group where participants used toothbrush and toothpaste plus interdental cleaning and mouth wash containing Chlorhexidine and mouth rinse containing fluoride. Group II represented participants who were given Miswak, whereas Group III represented participants who were given Miswak plus toothbrush and toothpaste. The incidence of new caries lesions was evaluated according to time by (T) where (T0) represented the baseline, (T1) after 3 months, (T₂) after 6 months (T₃) after 9 months, and (T₄) after 12 months.

The allocation sequence was kept concealed from the primary investigator and the operator could not be blinded because of the differences in the procedures of caries prevention applied in each group. However, the assessors were unaware of the intervention assigned to the patients therefore the assessors were not included in the preclinical assessment to be blinded.

Training for allocated participants

Participants in Group I were trained for tooth brushing, interdental cleaning by flossing and mouthwashes/mouth rinses. Participants in Group II were trained for using Miswak and participants in Group III were trained for Miswak and tooth brushing. Participants within Group I followed the standard preventive measures, who were brushing two times a day after breakfast and prior to bedtime and Pea-sized toothpaste containing fluoride was used. Flossing interdentally was done before bedtime. Chlorhexidine containing mouthwash was administered daily 10 mL of Hexitol for 1 min in the morning before breakfast and before tooth brushing for antibacterial action and 10 mL Ezafluor mouth rinse for 1 min before bedtime after tooth brushing to help in the remineralization process.

The participants were then offered a new set of manual brushes and dental floss at the beginning of this study and upon each follow-up periods.

Tooth brushing technique

Tooth brushing is characterized by a dual mode of action that is mechanically by tooth brushing and chemo-mechanically by toothpaste. The brushing technique of choice was the Bass technique as recommended by Rajwani et al.^[18] to standardize the brushing method.

The general instructions given during the training session were as follows:

1. Tooth brushing should be carried out twice daily in morning after breakfast and before bedtime.

2. Brushing should take at least 2 min.

3. Ensuring that the brush is at an angle of 45° to the gum line; the brush is moved slowly in a circular motion few times on each tooth for the outer and inner surface.

4. Brush the biting surfaces of the teeth, on the top and the bottom.

5. Clean the inner surfaces of the front teeth, slant the brush vertically for the upper teeth, and gently move the brush downwards from the gum for a few seconds.

6. For the lower teeth, pull the toothbrush gently upward from the gum for a few seconds.

7. Finally, spit out any remaining toothpaste. In this way, the fluoride in the toothpaste will help to protect the teeth.

Interdental cleaning

Participants for Group I were trained to use interdental cleaning using dental floss once a day before bedtime. 45 cm of floss was used and wrapped around one of middle fingers, with the rest wrapped around the opposite middle finger. The floss was held tightly between the thumbs and forefingers and gently inserted between the teeth. The floss was curved into a “C” shape against the side of the tooth and rubbed gently up and down, keeping it pressed against the tooth according to Slot et al.^[19] and Sambunjak et al.^[20]

Mouth washing and mouth rinsing

Mouth washing was used prior to brushing whereas mouth rinsing was used before bedtime after brushing for fluoride availability during nighttime. The importance and mechanism of action of Hexitol mouth wash used in this clinical trial were highlighted and explained with justification with other previous studies using chlorhexidine. Chlorohexidine mouthwash was used for 1 week per month to avoid its side effects. Varoni et al.^[21] demonstrated its importance to assist oral hygiene and professional prophylaxis especially in patients with high caries risk where it decreased the plaque and bleeding index.

Miswak use

For Groups II and III, Miswak was handed to each participant within the intervention group and they were taught and requested to use it twice daily. Presentations and directions were delivered for chewing stick users. It included the technique of preparation of working end of chewing sticks and its suitable cleaning technique. The working end of a thin bark fragment was removed and chewed. Chewing Miswak extracts fibers, resulting in a brush-like form that aids in quick tooth brushing. The suggested length for a stick is around 15 cm so that it can be quickly grabbed and carried about and the diameter was chosen to be 1.5 cm for surface cleaning and smaller miswak sticks with smaller diameter (1 cm) for interdental cleaning. There are two known strategies for restraining the Miswak. The first is the three-finger grip method, and the second is the five-finger grip method. Both methods were developed to ensure that were accessible and cleaned with ease and coordinated movements of the tool in the oral cavity. For standardization purposes, all participants were instructed to use the five-finger grip technique to clean the tooth surfaces. The miswak fibers were kept perpendicular to the tooth surface and lightly brushed them up and down, far from the gingival margins both on the buccal and lingual surfaces.^[4] The sticks which were not prepared were advised to be refrigerated at –4°C.^[14],[22]

Assessment (outcome assessment)

The development of new carious lesions was assessed every three months till 12 months using CPI probe by visual examination.^[14],[23] Participants were then rechecked for their plaque index after 12 months.

Data management

Data entry was done. All data of the trial were stored on a computer and encrypted using password in compliance with HIPAA privacy guide safeguards comprising protected health information prior to their disposal, securing medical records using lock and key or passcode, and restricting accessibility to keys or passcodes.

Statistical analysis

Categorical and ordinal data were presented as frequency and percentage values. Categorical data were analyzed using fisher’s exact test. Ordinal data were analyzed using Mann–Whitney U test for intergroup comparisons and Freidman’s test followed by Dunn’s post hoc test for intragroup comparison. The significance level was set at P ≤ 0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.1.0 for Windows.^[24]

Results

Demographic data

Seventy-eight students participated in the study and were randomly and equally allocated to the tested groups (i.e., 26 participants each). Fourteen (53.8%) participants of Group I were males and 13 (46.2%) were females, for Group II 13 (50.0%) were males and 13(50.0%) were females, and for Group III 18 (69.2%) were males and 8 (30.8%) were females. There was no statistically significant difference between tested groups regarding gender distribution (P = 0.440). During follow-up intervals, 3 participants from Group II and two participants from Group III dropped out of the study. Summary statistics for demographic data are presented in [Table 4].

Table 4: Gender distribution in different groups

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Caries risk assessment

221 cavities were observed and restored, 13 restorations were found in the 78 participants and with an average DMF of 3 per participant. No evidence of white spot lesion was found, heavy plaque deposits were observed showing mostly scores (2) denoting moderate accumulation of soft deposits within the gingival pocket or on the tooth and gingival margin which can be seen with the naked eye, and score (3) denoting abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. The type and frequency of diet revealed that the intake of diet is with a relatively high content of sugar or other caries inducing carbohydrates. The protective factors against caries used by these participants revealed not to be sufficient as 74.4% of them brush and their teeth once only per day, only 12.8% used interdental cleaning, whereas only 33.4% use of mouth wash and/or mouth rinse occasionally.

Plaque index

Results of inter and intragroup comparisons for plaque index scores presented in [Table 5]a showed that at baseline (T0) there was no significant difference between different groups (χ2 (2)=1.53, P = 0.467), with the majority of cases in all groups either having scores (2) or (3) which indicated moderate or abundant soft deposits within the gingival pocket or on the tooth and gingival margin. Similarly, after 12 months (T4) there was no significant difference between the different groups (χ2 (2)=0.89, P = 0.640), yet most of the cases in all groups either had (0) or (1) scores indicating no or minimal plaque that could be seen only after the application of disclosing solution or using the probe on the tooth surface. For intragroup comparisons in all groups, there was a significant increase of cases with (0) and (1) scores after the end of the follow-up period (P < 0.001).

Table 5a: Inter and intragroup comparisons of plaque index scores

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Results of intergroup comparisons of plaque scores based on clinical acceptability are presented in [Table 5]b, where scores (0) and score (1) are considered as clinically accepted, and scores of (2) and above are considered to be clinically unacceptable. Risk ratios were calculated for groups (II) and (III) in comparison to the control group. Risk ratios at baseline (T0) were all lower than (1) indicating lower risk than the control group. However, after 12 months (T4), risk ratios in both groups were higher than (1) indicating a higher risk.{Table 6)

DMF and incidence of new caries lesions

For DMF scoring statistical analysis was carried out for decayed and filled teeth. However, no statistical analysis was performed for missed teeth as there was no missing tooth in all participants.

I-Decayed

Results of inter and intragroup comparisons for decayed scores presented in [Table 6] showed that at baseline (T0) there was no significant difference between different groups (χ2 (2)=5.13, P = 0.077) with the majority of the cases in all groups having score (3). After 12 months (T4), all cases had score (0) (χ2 (2)=0.00, P = 1). For intragroup comparisons in all groups, the difference in scores between follow-up intervals was statistically significant (P < 0.001).

Table 6: Inter and intragroup comparisons of decayed scores

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II-Filled

Results of inter and intragroup comparisons for filled scores presented in [Table 7] showed that at baseline (T0) there was no significant difference between different groups (χ2 (2)=5.13, P = 0.077) with the majority of the cases in all groups having a score of (0), after 12 months (T4) all cases had score (3) (χ2 (2)=0.00, P = 1). For of intragroup comparisons in all groups, the difference in scores between follow-up intervals was statistically significant (P < 0.001).

Table 7: Inter and intragroup comparisons of filled scores

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Incidence of new carious lesions

Results of inter and intragroup comparisons for the incidence of new carious lesions presented in [Table 8]a showed that there was no incidence of new carious lesions in all groups at all follow-up intervals (χ2 (2)=0.00, P = 1). Clinical acceptability was determined in [Table 8]b using the same criteria employed with plaque scores. All risk ratios were above (1) indicating higher risk in Groups II and III in comparison to the control group.

Table 8a: Inter and intragroup comparisons of incidence of new carious lesions

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Table 8b: Inter and intragroup comparisons of the incidence of new carious lesion based on clinical acceptability

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Discussion

This randomized controlled clinical trial addressed the use of different oral hygiene tools and preventive measures such as Miswak, tooth brushing, chemotherapeutics, and dental floss interdental cleaning to prevent the incidence of new carious lesions and reduce the caries risk level.

This study was designed to respond partly to the call and recommendations of the results of the research on the status of oral health in Egypt conducted in 2010 by the World Health Organization (WHO) in collaboration with the Oral Health Department of the Ministry of Health and Population in Egypt who dictated the need to develop a national oral health plan to promote oral health in Egypt. The suggestion of efficient, economic, and compliant friendly tools for oral health care and user-friendly preventive programs could facilitate implementation of ideas and obtaining of promising results. Further, conducting a series of researches related to oral health care and promotion by different institutions in the 27 governorates in Egypt could be the nidus to help designing a National oral health plan in Egypt.

As Miswak stick is rich in chemical composition as mentioned in [Table 1]. So we tried to design a balanced arms of the study by giving fluoride, CHX (to cover the range of chemical components in miswak) in addition to toothbrush and dental floss for interdental cleaning in group I while group II was Miswak only and for Group III tooth brush and toothpaste were added to miswak.

Dental students were selected and addressed to perform this clinical trial as they could be the best ambassadors to start implementing research results and widen the base of the appropriate and sound oral health-related behaviors. This population was also an indication of the awareness level of this important category in order to identify and reinforce pitfalls. Moreover, risk ratio was calculated for plaque assessment and incidence of new carious lesions as clinical outcome to determine the clinical significance.

The demographic results of the current study revealed that there was no statistically significant difference in gender distribution and participants’ ages ranged between 18 and 25 years. Those who had a history of smoking or taking medications were excluded from this clinical trial as these factors could affect the salivary parameter and consequently the caries equation. Seventy-eight participants were chosen for this study with 5 cases dropping out during the time of follow-up. The students were juniors and were not yet exposed to dental curricula. A recommendation could be to emphasize information about dental decay as part of an introductory course for them as soon as they join the dental school or add information in some sort of extracurricular activities to render them dentally cultured.

The high caries risk population showed caries indicators limited protective factors. Consequently, participants could benefit from the preventive regimens and allow the assessment of the population who could turn from a high caries risk to a low caries risk to attain the ultimate goal.

Preventing dental caries relies on minimization of pathological factors and reinforcement of protective factors in order to reach the balance emphasized since 1997 in the studies performed by Featherstone et al.^[25] and all the way through to 2018 by the recommendations of the practice-based research network in San Francisco in collaboration with the American Academy of Cariology.

Patient education and training was crucial for the success of the work and consequently awareness session was run to explain the necessity of compliance and adherence to the required parameters during the research to control plaque and adopt an oral health-friendly dietary regimen. The understanding of the idea behind the caries equation could help in patient compliance which was strongly found in this research by strict participants’ compliance.

In the present study, regarding plaque index the results revealed that there was no participants recorded score 0 and no significance difference was observed between Group I, II and III at baseline (T0) and after 12 months (T4) follow-up whereas a statistical significant difference was observed between the baseline and after 12 months between the different groups. This dictates that the preventive measures successfully reduced the plaque deposits as denoted by the recorded scores which was mostly score 2 and 3 at the base line and turned to score 1 and 2 after 12 months. This could be due to the assimilation of the awareness formed by the participants during the education session before the trial. This is in accordance with Wainwright and Sheiham, 2014.^[25]

An assessment of the awareness level prior to education was necessary in order to pinpoint the baseline from which the study started. It was brought to the authors notice that results indicated that dental students suffered from untreated cavitated lesions and were not dentally cultured and aware about the basic oral health care hygiene measures that should be performed. 74.4% brushed once a day and a limited percentage used interdental flossing (12.8%) and mouth washes and rinses (33.4%). Further, only 12.8% paid visits to the dentist in spite of the fact that they are within the field. This was in accordance with the results published in 2014 by the Ministry of Health and population that indicated that 77% of the examined individuals do not brush their teeth on a regular basis and that 20% had never been to a dentist. Plaque scores revealed heavy deposits emphasizing that teeth cleaning was not performed adequately in 78% of the participants denoting the necessity of awareness, education and training.

Prevention of dental caries necessitates not only patient awareness and education but also mastering of the techniques to be employed. This latter pivotal pillar is almost always overlooked during the dental treatment session and hence its reinforcement is mandatory to close the cycle of awareness, education and training.

Caries risk assessment revealed cavitation, deep pits and fissures and insufficient protective factors which determine the likelihood of caries over a given duration as indicated by Reich E et al.^[26] or the possibility of alteration within the size or activity of lesions that were already present as indicated by Nozari et al. 2017.^[27]

It was also necessary to restore all cavities and clear up all plaque deposits in order to minimize the microbiome load and bring oral status to the same level in all participants prior to the start of the trial. There are three major components to the disease control phase: caries risk assessment and recommendations for modifications, caries elimination and provisional restorations and chemotherapeutic agents and defensive treatment

Training of the groups that will be utilizing the brushing technique was done using the Bass technique as it provided appropriate results according to Wainwright and Sheiham^[25] Interdental cleaning using flossing was recommended due to availability and being known by most personnel.^[28] The use of a Hexitol mouth wash and the Ezafluor mouth rinse was to mimic the range of therapeutic components of Miswak. Additionally, training of individuals to use Miswak was done for standardization purpose.

Anticaries products are vastly available and each one has its benefits, flaws or side effects. Therefore, finding effective agents that have benefits with fewer side effects is critical. Employing effective, easy to use products that need short time and easy steps to follow will allow success of the preventive regimen.

Miswak sticks as an effective way of oral hygiene measures was also a recommendation by World Health Organization WHO.^[29] Miswak is a naturally available single oral healthcare tool that proved to be effective for the control of plaque and has anticaries potentials. Since they differ greatly in their design and shape, the miswak’s bristles, unlike those of tooth brush are located alongside the long axis of its holder giving it a limited accessibility to the lingual surfaces or the interdental spaces, but it shows outstanding effects on the facial surfaces of the teeth. This was in disagreement with Eid et al.^[30] who mentioned that, unlike the tooth brush, which give access to all teeth surfaces and can reach distal tooth surfaces, especially on the posterior teeth, the miswak can’t reach such places. Miswak showed similar results in plaque removal when compared to tooth brushing in a comparative study by Batwa et al.^[31] Such effectiveness can be attributed to the mechanical cleansing, enhancing salivation, and leaching-out of antimicrobial substances found within miswak.^[32],[33] The cleaning effectiveness and upgrade of good oral health when using Miswak can be explained by; (1) the mechanical effects of its fibers,^[32] (2) the release of helpful substances like trimethyleamine, salvadorine, mustard oil, vitamin C, resins, flavodine, saponins, sterol, and fluoride or (3) a combination of both the fibers and the substances it releases. Additionally, Salvadora persica might propose a new approach for reducing the growth of dental caries via constraining the early bonding and succeeding biofilm creation of cariogenic bacteria. persica’s well-known antibacterial, antifungal, antiviral, anti-cariogenic, and anti-plaque properties. Miswak is considered a noble mastication stick for the purpose of cleansing teeth, oral hygiene, and food, as it has antioxidant enzymes, peroxidase, catalase, and Polyphenol oxidase, which are known for their synergistic actions.^{[34],[35],[36]} Accordingly, in a study by Patel et al.,^[37] patients with mild to moderate chronic generalized marginal gingivitis were grouped to better compare the effects achieved by using a tooth brush only to those achieved when tooth brush is combined with miswak. Such combinations showed promising results. Hence they recommended the usage of both tools to get maximum benefits from both the mechanical efficacy of the tooth brush and the chemical effects of miswak. Additionally, chewing sticks (Miswak) mechanical and chemical cleansing properties on oral tissues can surpass those gained by a tooth brush, thus it can be concluded that if used properly, a miswak can replace a tooth brush.^[38

In the current study],[ regarding the DMF counts],[ a statistical significance difference was found between T0 and T4 (p value 0.000). In all tested groups no statistical significance difference was detected between different groups based on risk ratio calculation],[ it was found that all decayed teeth found at the beginning of the trial were filled with no new lesion development at the end of through the whole trial time line. Regarding plaque index],[ the results of the present study revealed that there was statistical significance difference between different time intervals within each group separately. However],[ no statistical significance difference was detected between different groups. Moreover risk ratio revealed that the miswak was as effective as the other treatment regimens used in this study. This may signify the effectiveness of different protective methods in different groups. It is also recommended to have a longer follow up period to verify these findings. Moreover],[ these positive findings suggested that one single natural preventive product as (Miswak) was as effective as different sets of chemical mouth rinses],[ tooth brushes and interdental cleaning methods. Thus miswak could be considered as chemico-mechanical method for caries prevention. In addition to its usage simplicity and its relative low cost that might strengthen its clinical recommendation. However],[ more studies are required to evaluate the cost effectiveness of Miswak versus other preventive regimens assessed.

Regarding the clinical outcome (development of new caries lesion) the finding of the study revealed that the 78 participants who started the trial as high caries risk individuals turned to be low caries risk following the caries treatment],[ education and awareness session as well as following the 3 different preventive regimens adopted in the study. Also],[ comparison of numerical variables between the study groups revealed that no statical significance difference in plaque index score distribution between the different study groups was evidenced at 12 months. No new lesions were detected in all groups at different evaluation times throughout the trial indicating that the 3 different preventive regimens were successful and efficient. Thus],[ Miswak can play an effective role preventing the dental caries and this was in agreement with other authors who compared the effectiveness of S. persica mouth rinses to chlorhexidine and/or placebo mouth rinses in reducing plaque/cariogenic bacteria.^{[39],[40],[41]} This could be due to the organic compounds like saponins, flavonoids, alkaloids, tannins. It was concluded that using Miswak extract reduced plaque score significantly. Miswak could be considered a suitable oral hygiene alternative for use in people in different ages, socioeconomic backgrounds as well as health conditions, due to being efficient, safe, available, cost-effective, and ease in use.^{[42],[43],[44],[45],[46],[47]}

It could be noted that a mandatory part of the success of the preventive measure is linked to patient education and awareness. This recommendation was in line with the ideologies of Primary Health Care Approach which gives attention to prevention in public contribution. Miswak could be used unaccompanied or in conjunction with a conventional tooth brush to achieve optimal oral health and hygiene. Thus, the alternate hypothesis was rejected as using miswak did not show significant difference over using standard preventive measures using tooth brushing, flossing and mouth rinsing in high caries risk patients.

Conclusions

1. Miswak is an effective oral hygiene tool to be used solely for prevention of dental caries. Minimization of time, effort and cost could be done by employing a preventive regimen that includes miswak.

2. Miswak is equivalent in action to tooth brushing plus tooth paste containing fluoride, interdental cleaning using flossing and mouth wash containing Chlorhexidine and mouth rinse containing fluoride.

3. A low caries risk level could be attained by adopting patient education and preventive regimen.

4. Caries free subjects could be attained by adhering to the different preventive regimens conducted in this study

Clinical significance:

Miswak could be used unaccompanied or in conjunction with a conventional tooth brush to achieve optimal oral health and hygiene.

Consent statement

An informed consent with an easy Arabic language was signed by the recruited participants.

Acknowledgement

Not applicable.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Authors’ contributions

RRT: Primary author, concept designs, data extraction, writing original draft, methodology, resources.

EMF: Concept designs, data extraction, writing original draft, methodology, resources, conceptualization, validation, data curation, manuscript review, and guarantor.

SHI: Corresponding author, concept designs, data extraction, writing original draft, methodology, resources, conceptualization, validation, data curation, manuscript review, and guarantor.

Ethical policy and institutional review board statement

The study was then approved by the Ethical Committee, Faculty of Dentistry, Cairo University (18943) on 26-9-2018 and registered in the clinical trial.gov (NCT03732040) in September 2018.

Patient declaration of consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Data availability statement

The data that support the findings of this study are available from the corresponding author, on reasonable request.

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