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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00472173
Acronym
APEXMTA
Enrollment
34
Registered
2007-05-11
Start date
2007-05-01
Completion date
2011-05-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Necrosis

Keywords

Apexification, Pulp necrosis, Calcium hydroxide, MTA, pulp necrosis of an anterior immature tooth

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.

Detailed description

36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). These patients will be randomly divided into two groups: one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion: presence of a calcified apical barrier or not. Additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. This randomised prospective therapeutic study will allow to assess the ability of MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.

Interventions

DRUGMineral Trioxide Aggregate

Apexification treatment of the tooth with Mineral Trioxide Aggregate

DRUGCalcium hydroxide

Apexification treatment of the tooth with Calcium hydroxide

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

General disease * diabetes * immunosuppression of whatever origin (AIDS, drugs, …) * severe asthma * chronical disease requiring treatment * eating disorders (anorexia, bulimia, malnutrition, …) Oral disease * periodontal disease * Administration of corticoids in a period of 3 months preceding the inclusion * Patient with no social security cover

Design outcomes

Primary

MeasureTime frame
Main success criterion: presence of a calcified apical barrier or not at 3, 6 and 12 months30 days

Secondary

MeasureTime frame
Additional criterions :- presence of clinical symptoms or not- apical morphology - depth of this apical barrier At 3, 6 and 12 months12 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Jacques Lasfargues, Dentist PhD

Hôpital Bretonneau - Paris

STUDY_DIRECTORRaphaël SERREAU, MD, PhD

URC Paris Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026