title: Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: study protocol for a randomized controlled trial.
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
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov no. NCT00472173 (First inclusion: May 10, 2007; Last inclusion: April 23, 2009; study completed: April 15, 2010).
authors.affiliation: Service d'Odontologie Hôpital Bretonneau, 2 rue Carpeaux 75018 Paris, France. aurelie.beslot@yahoo.fr
authors.forename: Aurélie
authors.initials: A
authors.lastname: Beslot-Neveu
authors.forename: Eric
authors.initials: E
authors.lastname: Bonte
authors.forename: Bruno
authors.initials: B
authors.lastname: Baune
authors.forename: Raphaël
authors.initials: R
authors.lastname: Serreau
authors.forename: Fawzia
authors.initials: F
authors.lastname: Aissat
authors.forename: Laurent
authors.initials: L
authors.lastname: Quinquis
authors.forename: Sophie
authors.initials: S
authors.lastname: Grabar
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Lasfargues
mesh_terms: D000293:Adolescent; D017607:Aluminum Compounds / Q000627:therapeutic use*; D056624:Apexification / Q000379:methods*; D017610:Calcium Compounds / Q000627:therapeutic use*; D002126:Calcium Hydroxide / Q000627:therapeutic use*; D002648:Child; D003790:Dental Pulp Necrosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004338:Drug Combinations; D006801:Humans; D007180:Incisor / Q000000981:diagnostic imaging / Q000254:growth & development; D010087:Oxides / Q000627:therapeutic use*; D010297:Paris; D011446:Prospective Studies; D011859:Radiography; D012107:Research Design; D012387:Root Canal Filling Materials / Q000627:therapeutic use*; D017640:Silicates / Q000627:therapeutic use*; D013997:Time Factors; D019227:Tooth Apex / Q000000981:diagnostic imaging / Q000254:growth & development; D016896:Treatment Outcome
chemical_list: D017607:Aluminum Compounds; D017610:Calcium Compounds; D004338:Drug Combinations; D010087:Oxides; D012387:Root Canal Filling Materials; D017640:Silicates; C086631:mineral trioxide aggregate; D002126:Calcium Hydroxide