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OpenTrials
Completed

NCT Number: NCT00687037

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-aventis

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

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;

Treatment and study plan

cetylpyridinium chloride

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power

Important dates

Study start
2008
Primary completion
2008
First posted
May 30, 2008
Registry last updated
Feb 13, 2009

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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