Chlorhexidine Mouthrinses and Plaque Control

Not Applicable

Completed

• Conditions: Dental Plaque
• Interventions: Drug: Soludent; Drug: Synthodont

• Registration Number: NCT01138943
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2007-02
• Study Start: 2007-02
• Primary Completion: 2007-03
• Study Completion: 2007-04
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non alcohol chlorhexidine mouthrinse	Soludent	-
Chlorhexidine alcohol-base mouthrinse	Synthodont	-

Primary Outcome Measures

Name	Time	Method
Plaque Index (PI)at Day 1 and Day 7.	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

Name	Time	Method
Side effects	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.

Trial Locations

Locations (1)

Faculté de Médecine Dentaire; 🇲🇦 Rabat, Morocco