Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02656251
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Patricia Weidlich, Federal University of Rio Grande do Sul

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).

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: 0.12% Clorhexidine with alcohol Drug: placebo Drug: 0.12% Clorhexidine without alcohol Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: 0.12% Clorhexidine with alcohol
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
Drug: 0.12% Clorhexidine with alcohol
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
  • Periogard
  • No plak

Drug: placebo
Use of placebo every 12 hours for 04 days

Drug: 0.12% Clorhexidine without alcohol
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Name: Periogard

Experimental: 0.12% Clorhexidine without alcohol
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
Drug: 0.12% Clorhexidine with alcohol
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
  • Periogard
  • No plak

Drug: placebo
Use of placebo every 12 hours for 04 days

Drug: 0.12% Clorhexidine without alcohol
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Name: Periogard

Placebo Comparator: control
placebo 15ml every 12 hour for 4 days
Drug: 0.12% Clorhexidine with alcohol
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
  • Periogard
  • No plak

Drug: placebo
Use of placebo every 12 hours for 04 days

Drug: 0.12% Clorhexidine without alcohol
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Name: Periogard




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656251


Locations
Layout table for location information
Brazil
University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Layout table for investigator information
Study Director: Patricia Weidlich, PhD Federal University of Rio Grande do Sul

Layout table for additonal information
Responsible Party: Patricia Weidlich, Doctor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02656251     History of Changes
Other Study ID Numbers: URio Grande
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Patricia Weidlich, Federal University of Rio Grande do Sul:
biofilms
cross over trial
chlorhexidine

Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents