Chlorhexidine Mouthrinses and Plaque Control

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01138943
First received: June 7, 2010
Last updated: May 13, 2011
Last verified: February 2007
  Purpose

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 Intervention
Dental Plaque
Drug: Synthodont
Drug: Soludent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials

Resource links provided by NLM:


Further study details as provided by Hôpital Militaire De Rabat:

Primary Outcome Measures:
  • Plaque Index (PI)at Day 1 and Day 7. [ Time Frame: one week ] [ Designated as safety issue: No ]

    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 [ Time Frame: at day 7 ] [ Designated as safety issue: No ]
    On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.


Enrollment: 30
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine alcohol-base mouthrinse Drug: Synthodont

15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse

Other Name: Synthodont
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

Other Name: Soludent

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.

  Eligibility

Ages Eligible for Study:   20 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138943

Locations
Morocco
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
Investigators
Study Chair: Oumkeltoum Ennibi, Professor Faculté de Médecine Dentaire
  More Information

No publications provided

Responsible Party: Ennibi Oumkeltoum , Head of clinical Department of Periodontology, Faculté de Médecine Dentaire de Rabat
ClinicalTrials.gov Identifier: NCT01138943     History of Changes
Other Study ID Numbers: 1251/10, 1171
Study First Received: June 7, 2010
Last Updated: May 13, 2011
Health Authority: Morocco: Ministry of Public Health

Keywords provided by Hôpital Militaire De Rabat:
Chlorhexidine mouthrinse
Plaque control

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014