The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 19, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedOctober 23, 2019
October 1, 2019
3 months
October 19, 2019
October 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
quantitative measure of the change in saliva buffering capacity from baseline to one month and three months.
baseline, one month , three months
Study Arms (3)
Miswak
EXPERIMENTALMiswak sticks used twice daily, every 12 hours, for three months.
Grape Seed Extract
EXPERIMENTALGrape seed extract 6.5% mouthwash used twice daily, every 12 hours, for three months.
Fluoride Mouthwash
ACTIVE COMPARATOR0.05% fluoride mouthwash used twice daily, every 12 hours, for three months.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with high caries risk
- Males or females
- Medically free patients
- Patients approving to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al Azhar University
Cairo, Nasr City, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maha Niazy, Professor
Al-Azhar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
October 19, 2019
First Posted
October 23, 2019
Study Start
June 1, 2019
Primary Completion
August 31, 2019
Study Completion
October 1, 2019
Last Updated
October 23, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share