Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

This study is ongoing, but not recruiting participants.

First Received: February 15, 2008 Last Updated: February 25, 2008 History of Changes

Sponsored by:	Universidade Federal do Ceara
Information provided by:	Universidade Federal do Ceara
ClinicalTrials.gov Identifier:	NCT00624572

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Efficacy Study
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:

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, Ceará
Ramille Araújo Lima
Fortaleza, Ceará, Brazil, 60440-810

Sponsors and Collaborators

Universidade Federal do Ceara

More Information

No publications provided

Responsible Party:	Federal University of Ceará ( Ramille Araújo Lima )
Study ID Numbers:	CHX0784
Study First Received:	February 15, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00624572 History of Changes
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

Study placed in the following topic categories:

Tooth Diseases
Necrosis
Dental Pulp Necrosis
Dental Pulp Diseases
Stomatognathic Diseases

Additional relevant MeSH terms:

Tooth Diseases
Necrosis
Pathologic Processes

Dental Pulp Necrosis
Dental Pulp Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 04, 2009