Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation

Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02656251

Enrollment

Registered

2016-01-14

Start date

2015-07-31

Completion date

2015-12-31

Last updated

2016-01-14

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

Conditions

Dental Plaque

Keywords

biofilms, cross over trial, chlorhexidine

Brief summary

The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

Detailed description

This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Interventions

DRUG0.12% Clorhexidine with alcohol

Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days

DRUGplacebo

Use of placebo every 12 hours for 04 days

DRUG0.12% Clorhexidine without alcohol

Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* age from 18 years; * non-smokers; * have good general health; * present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.

Exclusion criteria

* • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation; * positive history of allergies at using Triclosan; * pregnant or lactating patients; * patients in use of fixed orthodontic appliance.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.	24hours	The presence of scores 0, 1 or 2 of the index Plaque Free Zone will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).

Countries

Brazil

Outcome results

None listed

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