Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

Dental Pulp Necrosis Clinical Trial

Official title:

Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00624572
• Other study ID #: CHX0784
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 15, 2008
• Last updated: February 25, 2008
• Start date: October 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2008
• Source: Universidade Federal do Ceara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Necrosis

Intervention

Drug:
• chlorexidine
Chlorexidine gel 1% during 7 days inside root canals

Locations

Country	Name	City	State
Brazil	Ramille Araújo Lima	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil,