Chlorhexidine Mouthrinses and Plaque Control

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01138943

Enrollment

Registered

2010-06-08

Start date

2007-02-28

Completion date

2007-04-30

Last updated

2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque

Keywords

Chlorhexidine mouthrinse, Plaque control

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.

Interventions

DRUGSynthodont

15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse

DRUGSoludent

15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026