Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss

June 26, 2022 updated by: Madiha Sultan, Fatima Jinnah Dental College

A Comparison of Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss in Patients With Periodontal Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Fatima Jinnah Dental College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Dental floss
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
Experimental: Group 2
Interdental brush
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6
Time Frame: baseline and 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Jinnah Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 26, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FatimaJDC420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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