Chlorhexidine Mouthrinses and Plaque Control
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Synthodont
Soludent
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Chlorhexidine mouthrinse, Plaque control
Eligibility Criteria
Inclusion Criteria:
- give written informed consent before entering the study
- accept to stop tooth cleaning for a week
Exclusion Criteria:
- 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
Sites / Locations
- Faculté de Médecine Dentaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chlorhexidine alcohol-base mouthrinse
non alcohol chlorhexidine mouthrinse
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Side effects
On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.
Full Information
NCT ID
NCT01138943
First Posted
June 7, 2010
Last Updated
May 13, 2011
Sponsor
Hôpital Militaire De Rabat
Collaborators
CCTD, Centre Hospitalier Ibn Sina,Morocco, Faculté de Médecine Dentaire de Rabat, Faculté de Médecine de Rabat, Mohammed V Souissi University
1. Study Identification
Unique Protocol Identification Number
NCT01138943
Brief Title
Chlorhexidine Mouthrinses and Plaque Control
Official Title
Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hôpital Militaire De Rabat
Collaborators
CCTD, Centre Hospitalier Ibn Sina,Morocco, Faculté de Médecine Dentaire de Rabat, Faculté de Médecine de Rabat, Mohammed V Souissi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Chlorhexidine mouthrinse, Plaque control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine alcohol-base mouthrinse
Arm Type
Active Comparator
Arm Title
non alcohol chlorhexidine mouthrinse
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Synthodont
Intervention Description
15 ml, tree times/day for 07 days
Arm: Chlorhexidine alcohol-base mouthrinse
Intervention Type
Drug
Intervention Name(s)
Soludent
Intervention Description
15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days
Arm: Experimental: non alcohol chlorhexidine mouthrinse
Primary Outcome Measure Information:
Title
Plaque Index (PI)at Day 1 and Day 7.
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Side effects
Description
On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.
Time Frame
at day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
give written informed consent before entering the study
accept to stop tooth cleaning for a week
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oumkeltoum Ennibi, Professor
Organizational Affiliation
Faculté de Médecine Dentaire
Official's Role
Study Chair
Facility Information:
Facility Name
Faculté de Médecine Dentaire
City
Rabat
ZIP/Postal Code
10 000
Country
Morocco
12. IPD Sharing Statement
Learn more about this trial
Chlorhexidine Mouthrinses and Plaque Control
We'll reach out to this number within 24 hrs