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Completed

NCT Number: NCT02656251

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

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.12% Clorhexidine with alcohol

Drug

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

Other names: Periogard, No plak

Placebo

Drug

Use of placebo every 12 hours for 04 days

0.12% Clorhexidine without alcohol

Drug

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

Other names: Periogard

Primary outcomes

  1. Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2016
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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