Antimicrobial Pulpotomy of Primary Molars
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...
Brief Summary
Official Title: “Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Universidade Federal de Goias Other
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01010451
