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Chlorhexidine Mouthrinses and Plaque Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01138943
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : May 16, 2011
CCTD, Centre Hospitalier Ibn Sina,Morocco
Faculté de Médecine Dentaire de Rabat
Faculté de Médecine de Rabat
Mohammed V Souissi University
Information provided by:
Hôpital Militaire De Rabat

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).

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Synthodont Drug: Soludent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
Study Start Date : February 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01138943

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Faculté de Médecine Dentaire
Rabat, Morocco, 10 000
Sponsors and Collaborators
Hôpital Militaire De Rabat
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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Study Chair: Oumkeltoum Ennibi, Professor Faculté de Médecine Dentaire
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Responsible Party: Ennibi Oumkeltoum , Head of clinical Department of Periodontology, Faculté de Médecine Dentaire de Rabat Identifier: NCT01138943    
Other Study ID Numbers: 1251/10
1171 ( Other Identifier: Comité d'Ethique de la Recherche Biomédicale (CERB) )
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: February 2007
Keywords provided by Hôpital Militaire De Rabat:
Chlorhexidine mouthrinse
Plaque control
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases