Chlorhexidine Mouthrinses and Plaque Control

May 13, 2011 updated by: Hôpital Militaire De Rabat

Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Rabat, Morocco, 10 000
        • Faculté de Médecine Dentaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chlorhexidine alcohol-base mouthrinse
Drug: Synthodont

15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse
Experimental: non alcohol chlorhexidine mouthrinse
Drug: Soludent

15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days

Arm: Experimental: non alcohol chlorhexidine mouthrinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index (PI)at Day 1 and Day 7.
Time Frame: one week

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: at day 7
On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.
at day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Militaire De Rabat

Collaborators

Mohammed V Souissi University
CCTD, Centre Hospitalier Ibn Sina,Morocco
Faculté de Médecine Dentaire de Rabat
Faculté de Médecine de Rabat

Investigators

  • Study Chair: Oumkeltoum Ennibi, Professor, Faculté de Médecine Dentaire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1251/10
  • 1171 (Comité d'Ethique de la Recherche Biomédicale (CERB))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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