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

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).

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Miswak; Other: Grape Seed Extract Mouthwash; Other: fluoride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt
      • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Maha Niazy, professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Cariostatic Agents; Fluorides; Sodium Fluoride; Proanthocyanidin; Grape Seed Extract
• Other Study ID Numbers: REC17-082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No