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Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Universidade Federal do Ceara.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: February 27, 2008
Last Update Posted: February 27, 2008
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:
Universidade Federal do Ceara
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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT00624572

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

Responsible Party: Ramille Araújo Lima, Federal University of Ceará
ClinicalTrials.gov Identifier: NCT00624572     History of Changes
Other Study ID Numbers: CHX0784
First Submitted: February 15, 2008
First Posted: February 27, 2008
Last Update Posted: February 27, 2008
Last Verified: February 2008

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

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