NCT00687037

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

May 27, 2008

Last Update Submit

February 12, 2009

Conditions

Healthy

Keywords

oral hygiene

Outcome Measures

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.

    21 days

Study Arms (1)

I

EXPERIMENTAL

Cetylpyridinium chloride during 21 days.

Drug: Cetylpyridinium chloride

Interventions

Cetylpyridinium chlorideDRUG
I

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Cetylpyridinium

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jaderson Lima, MD

    Sanofi-aventis administrative office Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2008

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

BR(1)