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

NCT ID: NCT02412358

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pulsar

Patients use Pulsar toothbrush for plaque removal

Group Type: ACTIVE_COMPARATOR

toothbrush

Intervention Type: DEVICE

Crossaction

Patients use Crossaction toothbrush for plaque removal

Group Type: ACTIVE_COMPARATOR

toothbrush

Intervention Type: DEVICE

Butler

Patients use Butler toothbrush for plaque removal

Group Type: ACTIVE_COMPARATOR

toothbrush

Intervention Type: DEVICE

Interventions

toothbrush

Intervention Type: DEVICE

Other Intervention Names

Pulsar, Crossaction, Butler toothbrush

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amir Moeintaghavi

Professor of Periodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Moeintaghavi, DDs., Msc.

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Sciences

Locations

Amir Moeintaghavi

Mashhad, Khorasan Razavi, Iran

Countries

Iran

Other Identifiers

86394

Identifier Type: -

Identifier Source: org_study_id