Antimicrobial Pulpotomy of Primary Molars

NCT ID: NCT01010451

Last Updated: 2009-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antimicrobial pulpotomy

Pulpotomy of primary molars with pulp inflammation or necrosis due to carious lesions using an antimicrobial paste

Group Type EXPERIMENTAL

Antimicrobial pulpotomy

Intervention Type PROCEDURE

Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.

Calcium hydroxide pulpectomy

Pulpectomy of primary molars with pulp inflammation or necrosis due to carious lesions using a calcium hydroxide paste as intracanal medication

Group Type ACTIVE_COMPARATOR

Calcium hydroxide pulpectomy

Intervention Type PROCEDURE

Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication

Interventions

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Antimicrobial pulpotomy

Pulpotomy of inflamed or necrotic pulp using an antimicrobial paste (chloramphenicol, tetracycline, zinc oxide/eugenol)as medication.

Intervention Type PROCEDURE

Calcium hydroxide pulpectomy

Pulpectomy of inflamed or necrotic pulp using a calcium hydroxide paste as medication

Intervention Type PROCEDURE

Other Intervention Names

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Antibacterial pulp therapy Antibacterial pulpotomy Non-vital pulpotomy

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Goias

OTHER

Sponsor Role lead

Responsible Party

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Dental School

Locations

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Dental School

Goiânia, Goiás, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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3222

Identifier Type: -

Identifier Source: org_study_id

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