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Antimicrobial Pulpotomy of Primary Molars

This study has been completed.
Sponsor:
Information provided by:
Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01010451
First received: November 6, 2009
Last updated: November 9, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Inflammation
Necrosis
 Procedure: Antimicrobial pulpotomy
Procedure: Calcium hydroxide pulpectomy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Goias:

Study Start Date: August 2000
Study Completion Date: August 2006
Arms Assigned Interventions
Experimental: Antimicrobial pulpotomy
Pulpotomy of primary molars with pulp inflammation or necrosis due to carious lesions using an antimicrobial paste
 Procedure: Antimicrobial pulpotomy
Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.
Other Names:
  • Antibacterial pulp therapy
  • Antibacterial pulpotomy
  • Non-vital pulpotomy
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
 Procedure: Calcium hydroxide pulpectomy
Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010451

Locations
Brazil
Dental School
Goiânia, Goiás, Brazil, 74605220
Sponsors and Collaborators
Universidade Federal de Goias
  More Information

No publications provided

Responsible Party: Universidade Federal de Goias, Dental School
ClinicalTrials.gov Identifier: NCT01010451     History of Changes
Other Study ID Numbers: 3222
Study First Received: November 6, 2009
Last Updated: November 9, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal de Goias:
pulpotomy
pulpectomy
primary teeth
dental care for children

Additional relevant MeSH terms:
Inflammation
Necrosis
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents
 Calcium, Dietary
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013