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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02412358
Other study ID # 86394
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2008
Est. completion date June 2009

Study information

Verified date January 2020
Source Mashhad University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2009
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
toothbrush


Locations

Country Name City State
Iran, Islamic Republic of Amir Moeintaghavi Mashhad Khorasan Razavi

Sponsors (1)

Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque Index it is an index used for scoring plaque accumulation 2 weeks
Primary Gingival index it is an index used for scoring gingival inflammation 2 weeks
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