Clincosm LogoSign in Get a demo

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

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT04136639
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
4
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Miswak
  • Other: Grape Seed Extract Mouthwash
  • Other: fluoride
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months. [Baseline, one month, 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.

    Secondary Outcome Measures

    1. quantitative measure of the change in saliva buffering capacity from baseline to one month and three months. [baseline, one month , 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al Azhar University Cairo Nasr City Egypt

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    • Study Director: Maha Niazy, Professor, Al-Azhar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Ahmed Abdel Moneim, Principle Investigator, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT04136639
    Other Study ID Numbers:
    • REC17-082
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Oct 23, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dental Caries
    Proanthocyanidin
    Grape Seed Extract
    Fluorides
    Sodium Fluoride

    Study Results

    No Results Posted as of Oct 23, 2019