Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: Cetylpyridinium chloride

• Registration Number: NCT00687037
• Lead Sponsor: Sanofi

Brief Summary

To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-02
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Integral buccal mucous (without oral pathologies);
• Normal odontological exams;

Exclusion Criteria

• Lactation or gestational risk or gestation;
• Use of Anti-inflammatory or immunosuppression drugs 15 days before the study;
• Being in odontological treatment;
• Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
• Personal history of allergic disease in the area to be treated;
• Allergic or atopic history;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Cetylpyridinium chloride	Cetylpyridinium chloride during 21 days.

Primary Outcome Measures

Name	Time	Method
Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product.	21 days

Trial Locations

Locations (1)

Sanofi-aventis; 🇧🇷 São Paulo, Brazil