Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
1 other identifier
interventional
35
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedJanuary 14, 2016
January 1, 2016
5 months
November 18, 2015
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
0.12% Clorhexidine with alcohol
ACTIVE COMPARATOR0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
0.12% Clorhexidine without alcohol
EXPERIMENTAL0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
control
PLACEBO COMPARATORplacebo 15ml every 12 hour for 4 days
Interventions
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Use of placebo every 12 hours for 04 days
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patricia Weidlich, PhD
Federal University of Rio Grande do Sul
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 18, 2015
First Posted
January 14, 2016
Study Start
July 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01