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

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656251
• Other study ID #: URio Grande
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2015
• Last updated: January 13, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• 0.12% Clorhexidine with alcohol
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
• placebo
Use of placebo every 12 hours for 04 days
• 0.12% Clorhexidine without alcohol
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days

Locations

Country	Name	City	State
Brazil	University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.	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).	24hours