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Antimicrobial Pulpotomy of Primary Molars

Primary Purpose

Inflammation, Necrosis

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Antimicrobial pulpotomy

Calcium hydroxide pulpectomy

About this trial

This is an interventional treatment trial for Inflammation focused on measuring pulpotomy, pulpectomy, primary teeth, dental care for children

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antimicrobial pulpotomy

Calcium hydroxide pulpectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01010451

First Posted

November 6, 2009

Last Updated

November 9, 2009

Sponsor

Universidade Federal de Goias

1. Study Identification

Unique Protocol Identification Number

NCT01010451

Brief Title

Antimicrobial Pulpotomy of Primary Molars

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal de Goias

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Necrosis

Keywords

pulpotomy, pulpectomy, primary teeth, dental care for children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

Antimicrobial pulpotomy

Arm Type

Experimental

Arm Description

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

Arm Title

Calcium hydroxide pulpectomy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Antimicrobial pulpotomy

Other Intervention Name(s)

Antibacterial pulp therapy, Antibacterial pulpotomy, Non-vital pulpotomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Calcium hydroxide pulpectomy

Intervention Description

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Dental School

City

Goiânia

State/Province

Goiás

ZIP/Postal Code

74605220

Country

Brazil

12. IPD Sharing Statement

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Antimicrobial Pulpotomy of Primary Molars

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