Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Universidade Federal do Ceara.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universidade Federal do Ceara
ClinicalTrials.gov Identifier:
NCT00624572
First received: February 15, 2008
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.


Condition Intervention Phase
Dental Pulp Necrosis
Drug: chlorexidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study

Further study details as provided by Universidade Federal do Ceara:

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: chlorexidine
    Chlorexidine gel 1% during 7 days inside root canals
  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children of both gender;
  • Without history of reactions or alergical diseases;
  • With situated age between 04 and 08 years of age
  • With normal standard of growth and development
  • Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.

Exclusion Criteria:

  • Patients with history of alergical diseases
  • Patients with allergy to any type of medicine and/or foods
  • Patients with comprometimento of its general state of health
  • Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
  • Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
  • With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
  • Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
  • Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624572

Locations
Brazil
Ramille Araújo Lima
Fortaleza, Ceará, Brazil, 60440-810
Sponsors and Collaborators
Universidade Federal do Ceara
  More Information

No publications provided

Responsible Party: Ramille Araújo Lima, Federal University of Ceará
ClinicalTrials.gov Identifier: NCT00624572     History of Changes
Other Study ID Numbers: CHX0784
Study First Received: February 15, 2008
Last Updated: February 25, 2008
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Ceara:
primary teeth
chlorexidine
root canal therapy
Pulpectomy

Additional relevant MeSH terms:
Dental Pulp Necrosis
Necrosis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014