Chlorhexidine Mouthrinses and Plaque Control
Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
2 other identifiers
interventional
30
1 country
1
Brief Summary
The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2007
Shorter than P25 for not_applicable
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
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 8, 2010
CompletedMay 16, 2011
February 1, 2007
28 days
June 7, 2010
May 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque Index (PI)at Day 1 and Day 7.
The clinical trial lasted 7 days (from Day 0 to Day 7). During this period all participants abstained from all mechanical oral hygiene procedures. On Day 0, subjects were randomly distributed in three groups: two test groups and one negative control group, and were instructed to rinse twice daily with the allocated mouthrinse during the experimental period. The clinical measurement: Plaque Index (PI) was recorded on Day 1 and Day 7.
one week
Secondary Outcomes (1)
Side effects
at day 7
Study Arms (2)
Chlorhexidine alcohol-base mouthrinse
ACTIVE COMPARATORnon alcohol chlorhexidine mouthrinse
EXPERIMENTALInterventions
15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse
15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse
Eligibility Criteria
You may qualify if:
- give written informed consent before entering the study
- accept to stop tooth cleaning for a week
You may not qualify if:
- less than 20 teeth;
- presence of periodontal disease
- presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances),
- associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection),
- use of antibiotics or other anti-inflammatory drugs during the latest months,
- known allergy against components of mouth rinses,
- pregnancy,
- smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hôpital Militaire De Rabatlead
- CCTD, Centre Hospitalier Ibn Sina,Moroccocollaborator
- Faculté de Médecine Dentaire de Rabatcollaborator
- Faculté de Médecine de Rabatcollaborator
- Mohammed V Souissi Universitycollaborator
Study Sites (1)
Faculté de Médecine Dentaire
Rabat, 10 000, Morocco
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Oumkeltoum Ennibi, Professor
Faculté de Médecine Dentaire
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 8, 2010
Study Start
February 1, 2007
Primary Completion
March 1, 2007
Study Completion
April 1, 2007
Last Updated
May 16, 2011
Record last verified: 2007-02