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Chlorhexidine Mouthrinses and Plaque Control

Primary Purpose

Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Synthodont
Soludent
Sponsored by
Hôpital Militaire De Rabat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Chlorhexidine mouthrinse, Plaque control

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

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
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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

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Chlorhexidine Mouthrinses and Plaque Control

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