Back to resultsPlaque Control Efficacy Between Interdental Brushes Versus Dental Floss
Primary Purpose
Periodontal Diseases, Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dental floss/Interdental brush
Sponsored by
About this trial
This is an interventional prevention trial for Periodontal Diseases
Eligibility Criteria
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
Sites / Locations
- Fatima Jinnah Dental College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Dental floss
Interdental brush
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05439785
First Posted
June 6, 2022
Last Updated
June 26, 2022
Sponsor
Fatima Jinnah Dental College
1. Study Identification
Unique Protocol Identification Number
NCT05439785
Brief Title
Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss
Official Title
A Comparison of Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss in Patients With Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Jinnah Dental College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Dental Plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Dental floss
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Interdental brush
Intervention Type
Device
Intervention Name(s)
Dental floss/Interdental brush
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6
Description
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)
Time Frame
baseline and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fatima Jinnah Dental College and Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss
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