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Antimicrobial Pulpotomy of Primary Molars

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ClinicalTrials.gov Identifier: NCT01010451
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : November 10, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Inflammation Necrosis Procedure: Antimicrobial pulpotomy Procedure: Calcium hydroxide pulpectomy Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy
Study Start Date : August 2000
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Calcium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010451


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

Responsible Party: Universidade Federal de Goias, Dental School
ClinicalTrials.gov Identifier: NCT01010451     History of Changes
Other Study ID Numbers: 3222
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

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

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