Clinical Comparision of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
Clinical Comparison of Three Types of Toothbrushes Pulsar, Crossaction and Butler on Gingivitis and Plaque Removal
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started May 2008
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 6, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedJanuary 7, 2020
January 1, 2020
6 months
April 6, 2015
January 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plaque Index
it is an index used for scoring plaque accumulation
2 weeks
Gingival index
it is an index used for scoring gingival inflammation
2 weeks
Study Arms (3)
Pulsar
ACTIVE COMPARATORPatients use Pulsar toothbrush for plaque removal
Crossaction
ACTIVE COMPARATORPatients use Crossaction toothbrush for plaque removal
Butler
ACTIVE COMPARATORPatients use Butler toothbrush for plaque removal
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- having any systematic disease which would influence the course of periodontal diseases or the response to the treatment
- smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amir Moeintaghavi
Mashhad, Khorasan Razavi, 91735-984, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Moeintaghavi, DDs., Msc.
Mashhad University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Periodontics
Study Record Dates
First Submitted
April 6, 2015
First Posted
April 9, 2015
Study Start
May 1, 2008
Primary Completion
November 1, 2008
Study Completion
June 1, 2009
Last Updated
January 7, 2020
Record last verified: 2020-01