- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04713566
Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health (RCT)
ABSTRACT:
OBJECTIVE: To compare the clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash on oral health of socially deprived madrasa girls.
METHODS: Girls aged 18-22 years living permanently in a madrasa of Multan city will be recruited. Sample size and trial duration will be determined using the American Dental Association guidelines. Participants will be randomized into two interventional groups; A and B and will be either provided with Salvadora persica oral rinse and commercial Listerein mouth wash respectively. Pre, mid and post-intervention examinations will be executed by a blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis will include descriptive statistics and two sample independent t-tests. The p-value of <0.05 will be considered significant at 95 % confidence level.
KEY WORDS: Dental plaque, Gingivitis, Miswak, Mouthwash
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aeeza Malik, BDS, MDS
- Phone Number: +923089162634
- Email: aeezamalik@gmail.com
Study Locations
-
-
Punjab
-
Multān, Punjab, Pakistan, 66000
- Aeeza Malik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria:
- Participants/girls with any medical or dental disease,
- Participants/girls with any dental prosthesis,
- Those taken antibiotics in last 6 months,
- Those received any periodontal therapy in last 3 months
Inclusion Criteria:
*Participants with at least 10 sites of chronic mild gingivitis with bleeding on probing but not having periodontal pockets of greater than 3mm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
will be using Salvadora Persica oral rinse
|
natural and commercial oral rinses were compared for efficacy
|
Experimental: Group B
will be using Commercial Phenolic mouthwash.
|
natural and commercial oral rinses were compared for efficacy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plaque and gingivitis scores
Time Frame: 6 months
|
Dental examination will be conducted at baseline, then after 3 and 6 months, that is, Pre-Interventional, Mid Intervention and Post-Interventional phases respectively.
It will be executed on inclined chairs in day light using a sterilized dental mirror and CPITN (Community Periodontal Index of Treatment Need) probe.
This probe has a ball ended tip with a diameter of 0.5mm.
This probe have two coloured bands of 2mm graduations each, one at 3.5 to 5.5mm and second at 8.5 to 11.5mm.
These bands determine the bleeding on probing which correspond to respective gingival score as per Loe and Silness Gingival index (1962)
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aeeza Malik, BDS, MDS, Multan Medical & Dental College
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMDC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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