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

NCT ID: NCT04136639

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-10-01

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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Miswak

Miswak sticks used twice daily, every 12 hours, for three months.

Group Type EXPERIMENTAL

Miswak

Intervention Type OTHER

sticks

Grape Seed Extract

Grape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months.

Group Type EXPERIMENTAL

Grape Seed Extract Mouthwash

Intervention Type OTHER

Mouthwash

Fluoride Mouthwash

0.05% fluoride mouthwash used twice daily, every 12 hours, for three months.

Group Type ACTIVE_COMPARATOR

fluoride

Intervention Type OTHER

mouthwash

Interventions

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Miswak

sticks

Intervention Type OTHER

Grape Seed Extract Mouthwash

Mouthwash

Intervention Type OTHER

fluoride

mouthwash

Intervention Type OTHER

Other Intervention Names

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silvadora persica 95% proanthocyanidins 0.05% sodium fluoride

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Hala Ahmed Abdel Moneim

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha Niazy, Professor

Role: STUDY_DIRECTOR

Al-Azhar University

Locations

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Al Azhar University

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC17-082

Identifier Type: -

Identifier Source: org_study_id

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