There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be...
Date First Received: November 6, 2009
Last Updated: November 9, 2009
Verified by: Universidade Federal de Goias, November 2009
Clinical Trial Phase: Phase 4 | Start Date: August 2000
Overall Status: Completed
Brief Summary
Official Title: “Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy”
Condition Keyword(s):
There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Procedure: Antimicrobial pulpotomy
- Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.
- Procedure: Calcium hydroxide pulpectomy
- Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Antimicrobial pulpotomy
- Pulpotomy of primary molars with pulp inflammation or necrosis due to carious lesions using an antimicrobial paste
- Active Comparator: Calcium hydroxide pulpectomy
- Pulpectomy of primary molars with pulp inflammation or necrosis due to carious lesions using a calcium hydroxide paste as intracanal medication
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy children (ASA PS 1)
- Children presenting one or more primary molar with pulp inflammation or necrosis due to carious lesion and indicated for endodontic therapy
Exclusion Criteria:
- Lost to follow-up
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Universidade Federal de Goias
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010451
Study ID Number: 3222
ClinicalTrials.gov Identifier: NCT01010451
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
