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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2010

Last Updated Date

May 13, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01138943 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chlorhexidine Mouthrinses and Plaque Control

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Dental Plaque

Intervention ^ICMJE

Drug: Synthodont
15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse

Other Name: Synthodont
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

Study Arm (s)

Active Comparator: Chlorhexidine alcohol-base mouthrinse
Intervention: Drug: Synthodont
Experimental: non alcohol chlorhexidine mouthrinse
Intervention: Drug: Soludent

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Morocco

Administrative Information

NCT Number ^ICMJE

NCT01138943

Other Study ID Numbers ^ICMJE

1251/10, 1171

Has Data Monitoring Committee

Responsible Party

Ennibi Oumkeltoum , Head of clinical Department of Periodontology, Faculté de Médecine Dentaire de Rabat

Study Sponsor ^ICMJE

Hôpital Militaire De Rabat

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Chair:

Oumkeltoum Ennibi, Professor

Faculté de Médecine Dentaire

Information Provided By

Hôpital Militaire De Rabat

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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