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OpenTrials
Completed

NCT Number: NCT00472173

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Bretonneau

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mineral Trioxide Aggregate

Drug

Apexification treatment of the tooth with Mineral Trioxide Aggregate

Calcium hydroxide

Drug

Apexification treatment of the tooth with Calcium hydroxide

Primary outcomes

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

    Time frame: 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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: APEXMTA

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 11, 2007
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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