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OpenTrials
Completed

NCT Number: NCT02412358

Clinical Comparision 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.

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Key information

Conditions

Healthy Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amir Moeintaghavi

Mashhad, Razavi Khorasan Province, 91735-984, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toothbrush

Device

Other names: Pulsar, Crossaction, Butler toothbrush

Primary outcomes

  1. Plaque Index

    Time frame: 2 weeks

    it is an index used for scoring plaque accumulation

  2. Gingival index

    Time frame: 2 weeks

    it is an index used for scoring gingival inflammation

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Apr 9, 2015
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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