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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687037
First Posted: May 30, 2008
Last Update Posted: February 13, 2009
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.
Information provided by:
Sanofi
  Purpose
To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.

Condition Intervention Phase
Healthy Drug: Cetylpyridinium chloride Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. [ Time Frame: 21 days ]

Enrollment: 30
Study Start Date: January 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Cetylpyridinium chloride during 21 days.
Drug: Cetylpyridinium chloride

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
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): NCT00687037


Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, MD Sanofi-aventis administrative office Brazil
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00687037     History of Changes
Other Study ID Numbers: CPYRY_L_03930
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Sanofi:
oral hygiene

Additional relevant MeSH terms:
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents