NCT01010451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

First QC Date

November 6, 2009

Last Update Submit

November 9, 2009

Conditions

InflammationNecrosis

Keywords

pulpotomypulpectomyprimary teethdental care for children

Study Arms (2)

Antimicrobial pulpotomy

EXPERIMENTAL

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

Procedure: Antimicrobial pulpotomy

Calcium hydroxide pulpectomy

ACTIVE COMPARATOR

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

Interventions

Antimicrobial pulpotomyPROCEDURE

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

Also known as: Antibacterial pulp therapy, Antibacterial pulpotomy, Non-vital pulpotomy
Antimicrobial pulpotomy
Calcium hydroxide pulpectomyPROCEDURE

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

Calcium hydroxide pulpectomy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School

Goiânia, Goiás, 74605220, Brazil

Location

MeSH Terms

Conditions

InflammationNecrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 10, 2009

Study Start

August 1, 2000

Study Completion

August 1, 2006

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

BR(1)