The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract

Study Overview
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Brief Summary
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Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE).

Detailed Description
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Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily for three month. Saliva samples were collected at base line and after one month and three month. Assessment of bacterial count and saliva buffering capacity were performed at base line and after one and three month.

Official Title
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The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Miswak
* Other: Grape Seed Extract Mouthwash
* Other: fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with high caries risk Males or females Medically free patients Patients approving to participate in the study Exclusion Criteria: Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination Patients had history of professional cleaning in the last 15 days Patients with exposed pulp Evidence of parafunctional habits Patients with developmental dental anomalies Patients undergoing or will start orthodontic treatment Patients with removable prosthesis Periapical Abscess or Fistula

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miswak<br>Miswak sticks used twice daily, every 12 hours, for three months. | Other: Miswak<br>* sticks<br>* Other names: silvadora persica;|
| Experimental: Grape Seed Extract<br>Grape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months. | Other: Grape Seed Extract Mouthwash<br>* Mouthwash<br>* Other names: 95% proanthocyanidins;|
| Active Comparator: Fluoride Mouthwash<br>0.05% fluoride mouthwash used twice daily, every 12 hours, for three months. | Other: fluoride<br>* mouthwash<br>* Other names: 0.05% sodium fluoride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months. | the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline,after one month and after three months. Every time samples were incubated with Mitiis Salivaris with Bacitricin and 20% sucrose for streptococcus mutans count. | Baseline, one month, three months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative measure of the change in saliva buffering capacity from baseline to one month and three months. | the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline, after one month and after three months. each time, saliva buffering capacity was measured using Hand Held pH meter and 0.1 mol/l hydrochloric acid that was titrated to the tested saliva. | baseline, one month , three months |