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Antimicrobial Pulpotomy of Primary Molars

This study has been completed.
Information provided by:
Universidade Federal de Goias Identifier:
First received: November 6, 2009
Last updated: November 9, 2009
Last verified: November 2009
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
Procedure: Antimicrobial pulpotomy
Procedure: Calcium hydroxide pulpectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01010451

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

Responsible Party: Universidade Federal de Goias, Dental School Identifier: NCT01010451     History of Changes
Other Study ID Numbers: 3222
Study First Received: November 6, 2009
Last Updated: November 9, 2009

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

Additional relevant MeSH terms:
Pathologic Processes
Calcium, Dietary
Anti-Bacterial Agents
Anti-Infective Agents
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 26, 2017