Chlorhexidine Mouthrinses and Plaque Control

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138943
• Other study ID #: 1251/10
• Secondary ID: 1171
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: May 13, 2011
• Start date: February 2007
• Est. completion date: April 2007

Study information

• Verified date: February 2007
• Source: Hôpital Militaire De Rabat
• Contact: n/a
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 25 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Synthodont
15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse
• Soludent
15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse

Locations

Country	Name	City	State
Morocco	Faculté de Médecine Dentaire	Rabat

Sponsors (5)

Lead Sponsor	Collaborator
Hôpital Militaire De Rabat	CCTD, Centre Hospitalier Ibn Sina,Morocco, Faculté de Médecine de Rabat, Faculté de Médecine Dentaire de Rabat, Mohammed V Souissi University

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index (PI)at Day 1 and Day 7.	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	No
Secondary	Side effects	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	No