NCT00472173

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

May 10, 2007

Last Update Submit

March 2, 2026

Conditions

Dental Pulp Necrosis

Keywords

ApexificationPulp necrosisCalcium hydroxideMTApulp necrosis of an anterior immature tooth

Outcome Measures

Primary Outcomes (1)

  • Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months

    30 days

Secondary Outcomes (1)

  • Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months

    12 months

Study Arms (2)

Calcium hydroxide

ACTIVE COMPARATOR
Drug: Calcium hydroxide

MTA

EXPERIMENTAL
Drug: Mineral Trioxide Aggregate

Interventions

Calcium hydroxideDRUG

Apexification treatment of the tooth with Calcium hydroxide

Calcium hydroxide
Mineral Trioxide AggregateDRUG

Apexification treatment of the tooth with Mineral Trioxide Aggregate

MTA

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Indication of apexification treatment of an anterior immature tooth
  • Patients aged 6 to 18
  • Enlightened agreement of the patient and his/her legal representatives
  • Prerequisite medical examination

You may not qualify if:

  • General disease
  • diabetes
  • immunosuppression of whatever origin (AIDS, drugs, …)
  • severe asthma
  • chronical disease requiring treatment
  • eating disorders (anorexia, bulimia, malnutrition, …) Oral disease
  • periodontal disease
  • Patient with no social security cover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bretonneau

Paris, 75018, France

Location

Related Publications (1)

  • Beslot-Neveu A, Bonte E, Baune B, Serreau R, Aissat F, Quinquis L, Grabar S, Lasfargues JJ. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial. Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.

    PMID: 21752247RESULT

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

mineral trioxide aggregateCalcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Jean-Jacques Lasfargues, Dentist PhD

    Hôpital Bretonneau - Paris

    PRINCIPAL INVESTIGATOR

  • Raphaël SERREAU, MD, PhD

    URC Paris Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2010

Study Completion

May 1, 2011

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

FR(1)