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NCT01010451 Clinical Trial

Antimicrobial Pulpotomy of Primary Molars

Inflammation Clinical Trial

Official title:
Survival of Primary Molars Treated With Antimicrobial Pulpotomy or Calcium Hydroxide Pulpectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01010451
Other study ID # 3222
Secondary ID
Status Completed
Phase Phase 4
First received November 6, 2009
Last updated November 9, 2009
Start date August 2000
Est. completion date August 2006

Study information
Verified date November 2009
Source Universidade Federal de Goias
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Antimicrobial pulpotomy
Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.
• Calcium hydroxide pulpectomy
Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication

Locations
Country Name City State
Brazil Dental School Goiânia Goiás

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

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