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.

Abstract

Background: Pulp necrosis is one of the main complications 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 prospective randomized clinical trial is to compare Mineral Trioxide Aggregate(MTA)with Calcium Hydroxide(CH)as materials used to induce root-end closure in necrotic permanent immature incisors.

Methods/design: This study, promoted by AP-HP, was approved by the ethics committee(CPP Paris Ile de France IV). 34 children aged from 6 to 18 years and presenting a non-vital permanent incisor are selected. Prior to treatment, an appropriate written consent has to be obtained from both parents and from children. Patients are then randomly assigned to either the MTA(experimental)or CH(control)groups. Recalls are performed after 3, 6 and 12 months to determine the presence or absence of a calcified apical barrier through the use of clinical and radiographic exams. Additional criteria such as clinical symptoms, apical radiolucencies, periapical index(PAI)are also noted.

Trial registration: ClinicalTrials.gov no. NCT00472173 (First inclusion: May 10, 2007; Last inclusion: April 23, 2009; study completed: April 15, 2010).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Aluminum Compounds / therapeutic use*
  • Apexification / methods*
  • Calcium Compounds / therapeutic use*
  • Calcium Hydroxide / therapeutic use*
  • Child
  • Dental Pulp Necrosis / diagnostic imaging
  • Dental Pulp Necrosis / therapy*
  • Drug Combinations
  • Humans
  • Incisor* / diagnostic imaging
  • Incisor* / growth & development
  • Oxides / therapeutic use*
  • Paris
  • Prospective Studies
  • Radiography
  • Research Design*
  • Root Canal Filling Materials / therapeutic use*
  • Silicates / therapeutic use*
  • Time Factors
  • Tooth Apex* / diagnostic imaging
  • Tooth Apex* / growth & development
  • Treatment Outcome

Substances

  • Aluminum Compounds
  • Calcium Compounds
  • Drug Combinations
  • Oxides
  • Root Canal Filling Materials
  • Silicates
  • mineral trioxide aggregate
  • Calcium Hydroxide

Associated data

  • ClinicalTrials.gov/NCT00472173