Back to resultsThe Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Miswak
Grape Seed Extract Mouthwash
fluoride
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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
Sites / Locations
- Al Azhar University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Miswak
Grape Seed Extract
Fluoride Mouthwash
Arm Description
Miswak sticks used twice daily, every 12 hours, for three months.
Grape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months.
0.05% fluoride mouthwash used twice daily, every 12 hours, for three months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04136639
Brief Title
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
Official Title
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
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
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miswak
Arm Type
Experimental
Arm Description
Miswak sticks used twice daily, every 12 hours, for three months.
Arm Title
Grape Seed Extract
Arm Type
Experimental
Arm Description
Grape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months.
Arm Title
Fluoride Mouthwash
Arm Type
Active Comparator
Arm Description
0.05% fluoride mouthwash used twice daily, every 12 hours, for three months.
Intervention Type
Other
Intervention Name(s)
Miswak
Other Intervention Name(s)
silvadora persica
Intervention Description
sticks
Intervention Type
Other
Intervention Name(s)
Grape Seed Extract Mouthwash
Other Intervention Name(s)
95% proanthocyanidins
Intervention Description
Mouthwash
Intervention Type
Other
Intervention Name(s)
fluoride
Other Intervention Name(s)
0.05% sodium fluoride
Intervention Description
mouthwash
Primary Outcome Measure Information:
Title
quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months.
Description
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.
Time Frame
Baseline, one month, three months.
Secondary Outcome Measure Information:
Title
quantitative measure of the change in saliva buffering capacity from baseline to one month and three months.
Description
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.
Time Frame
baseline, one month , three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Niazy, Professor
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Al Azhar University
City
Cairo
State/Province
Nasr City
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
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