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

January 5, 2020 updated by: Amir Moeintaghavi, Mashhad University of Medical Sciences

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

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

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 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • smoking

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsar
Patients use Pulsar toothbrush for plaque removal
Device: toothbrush
Other Names:
  • Pulsar, Crossaction, Butler toothbrush
Active Comparator: Crossaction
Patients use Crossaction toothbrush for plaque removal
Device: toothbrush
Other Names:
  • Pulsar, Crossaction, Butler toothbrush
Active Comparator: Butler
Patients use Butler toothbrush for plaque removal
Device: toothbrush
Other Names:
  • Pulsar, Crossaction, Butler toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 2 weeks
it is an index used for scoring plaque accumulation
2 weeks
Gingival index
Time Frame: 2 weeks
it is an index used for scoring gingival inflammation
2 weeks

Collaborators and Investigators

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

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: Amir Moeintaghavi, DDs., Msc., Mashhad University Of Medical Sciences

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

May 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86394

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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