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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04713566
Other study ID # MMDC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date September 30, 2021

Study information

Verified date January 2021
Source Multan Medical And Dental College
Contact Aeeza Malik, BDS, MDS
Phone +923089162634
Email aeezamalik@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 30, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
oral rinces
natural and commercial oral rinses were compared for efficacy

Locations

Country Name City State
Pakistan Aeeza Malik Multan Punjab

Sponsors (1)

Lead Sponsor Collaborator
Multan Medical And Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 6 months
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