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Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth

NCT00472173 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-03-04

No results posted yet for this study

Summary

Pulp necrosis is one of the main complication of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.The aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the reference treatment based on calcium hydroxide repeated stimulations.

Conditions

  • Dental Pulp Necrosis

Interventions

DRUG

Mineral Trioxide Aggregate

Apexification treatment of the tooth with Mineral Trioxide Aggregate

DRUG

Calcium hydroxide

Apexification treatment of the tooth with Calcium hydroxide

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Jacques Lasfargues, Dentist PhD · Hôpital Bretonneau - Paris

  • Raphaël SERREAU, MD, PhD · URC Paris Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-11-30
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472173 on ClinicalTrials.gov