Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health (RCT)
Primary Purpose
Plaque, Dental
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
oral rinces
Sponsored by
About this trial
This is an interventional prevention trial for Plaque, Dental focused on measuring Dental plaque, Gingivitis, Miswak, Mouthwash
Eligibility Criteria
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
Sites / Locations
- Aeeza Malik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
will be using Salvadora Persica oral rinse
will be using Commercial Phenolic mouthwash.
Outcomes
Primary Outcome Measures
plaque and gingivitis scores
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04713566
First Posted
January 11, 2021
Last Updated
January 14, 2021
Sponsor
Multan Medical And Dental College
1. Study Identification
Unique Protocol Identification Number
NCT04713566
Brief Title
Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health
Acronym
RCT
Official Title
Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Multan Medical And Dental College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
Comparative clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash will be studied on the oral health of socially deprived madrasa girls. 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 were 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental
Keywords
Dental plaque, Gingivitis, Miswak, Mouthwash
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
will be using Salvadora Persica oral rinse
Arm Title
Group B
Arm Type
Experimental
Arm Description
will be using Commercial Phenolic mouthwash.
Intervention Type
Other
Intervention Name(s)
oral rinces
Intervention Description
natural and commercial oral rinses were compared for efficacy
Primary Outcome Measure Information:
Title
plaque and gingivitis scores
Description
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)
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aeeza Malik, BDS, MDS
Phone
+923089162634
Email
aeezamalik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aeeza Malik, BDS, MDS
Organizational Affiliation
Multan Medical & Dental College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aeeza Malik
City
Multān
State/Province
Punjab
ZIP/Postal Code
66000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health
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