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Clinical Trials/NCT02412358
NCT02412358CompletedNot Applicable

Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal

Mashhad University of Medical Sciences2 sites in 2 countries30 target enrollmentStarted: May 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Plaque Index

Study Overview

Brief Summary

  • Objective: To compare clinical results of three types of manual tooth brushes on gingivitis and plaque removal efficacy.
  • Material and Methods: This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Detailed Description

This study is a single blind randomized trial with crossover design which involved 30 periodontally healthy individuals. At baseline professional plaque removal and oral hygiene instruction are performed for all the students, then they are asked to avoid brushing for 1-2 days. Thereafter plaque and gingivitis scores are measured using plaque and gingival indices (PI and GI). Then subjects are instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices are assessed again. After passing one-week period for wash out, subjects don't brush for 1-2 days and indices are recorded again. The same procedure are done for Cross action, and Butler 411 tooth brushes respectively.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • having at least five teeth in each quadrant;
  • no partial denture;
  • no orthodontic banding or retention wires;
  • no oral lesions or sites with probing pockets depth ≥ 5 mm;
  • routine use of a manual toothbrush.

Exclusion Criteria

  • having any systematic disease which would influence the course of periodontal diseases or the response to the treatment

Outcomes

Primary Outcomes

Plaque Index

Time Frame: 2 weeks

it is an index used for scoring plaque accumulation

Gingival index

Time Frame: 2 weeks

it is an index used for scoring gingival inflammation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amir Moeintaghavi

Professor of Periodontics

Mashhad University of Medical Sciences

Study Sites (2)

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