Back to resultsClinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
toothbrush
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring toothbrushing, plaque control, gingivitis
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
Sites / Locations
- Amir Moeintaghavi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Pulsar
Crossaction
Butler
Arm Description
Patients use Pulsar toothbrush for plaque removal
Patients use Crossaction toothbrush for plaque removal
Patients use Butler toothbrush for plaque removal
Outcomes
Primary Outcome Measures
Plaque Index
it is an index used for scoring plaque accumulation
Gingival index
it is an index used for scoring gingival inflammation
Secondary Outcome Measures
Full Information
NCT ID
NCT02412358
First Posted
April 6, 2015
Last Updated
January 5, 2020
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02412358
Brief Title
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Official Title
Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
toothbrushing, plaque control, gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsar
Arm Type
Active Comparator
Arm Description
Patients use Pulsar toothbrush for plaque removal
Arm Title
Crossaction
Arm Type
Active Comparator
Arm Description
Patients use Crossaction toothbrush for plaque removal
Arm Title
Butler
Arm Type
Active Comparator
Arm Description
Patients use Butler toothbrush for plaque removal
Intervention Type
Device
Intervention Name(s)
toothbrush
Other Intervention Name(s)
Pulsar, Crossaction, Butler toothbrush
Primary Outcome Measure Information:
Title
Plaque Index
Description
it is an index used for scoring plaque accumulation
Time Frame
2 weeks
Title
Gingival index
Description
it is an index used for scoring gingival inflammation
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Moeintaghavi, DDs., Msc.
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amir Moeintaghavi
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735-984
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
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