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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05439785
Other study ID # FatimaJDC420
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Fatima Jinnah Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 30, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - All patients above 18 years of age with gingivitis - patients of both gender Exclusion Criteria: - patients who refuse participate in the study - patients with systemic medical problems - patients using medications that may affect gingival tissue (overgrowth/bleeding) - patients habitual of betel nut/tobacco smoking/substance abuse - patients with fluorosis or any other enamel and dentinal deformity - pregnant women - patients undergoing orthodontic treatment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dental floss/Interdental brush
Initially plaque disclosing tablets were used to disclose plaque and plaque and bleeding scores will be recoded. After mechanical plaque debrided, instructions regarding the allocated interdental device given to the patient along with motivation to continue practicing good oral hygiene. After six weeks patients were recalled for reevaluation

Locations

Country Name City State
Pakistan Fatima Jinnah Dental College and Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Fatima Jinnah Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6 Silness and Loe Plaque Index and O'Leary et al plaque index are used as tools to measure plaque score by disclosing plaque, using a chewable plaque disclosing tablet. Possible score range from 0 (absence of microbial plaque) to 3 (large amount of plaque in sulcus or pocket along the free gingiva margin). Change = ( week 6 score - baseline score) baseline and week 6
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