Clinical trial NCT03855501: Apexification Treatment With MTA(Mineral Trioxide Aggregate) and Ca(OH)2
Official title: Delayed Apexification Treatment With MTA and Ca(OH)2 of Non-vital Immature Teeth in Adults: A Prospective Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immature Teeth
Keywords: apexification treatment
calcium hydroxide
mineral trioxide aggregate
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ninety immature teeth with necrotic pulps and periapical lesions on patients (aged 16-40y) were treated with AT using MTA (45 teeth) or CH (45 teeth) between 2015 and 2018. The patients were contacted for follow-up examination at 12 to 48 months after treatment. The treatment outcome based on clinical and radiographic criteria was assessed by calibrated examiners and dichotomized as "healed+healing" or "not healed". The age, gender, stage of root development, preoperative signs and symptoms of apical periodontitis and size of periapical lesion were recorded.

Detailed description: The aim of the study was to evaluate and compare the influence of various predictors on outcomes of apexification treatment (AT) using either mineral trioxide aggregate (MTA) or calcium hydroxide (CH) to treat permanent immature anterior teeth with necrotic pulps and periapical lesions in adults. Ninety immature teeth with necrotic pulps and periapical lesions on patients (aged 16-40y) were treated with AT using MTA (45 teeth) or CH (45 teeth) between 2015 and 2018. The patients were contacted for follow-up examination at 12 to 48 months after treatment. The treatment outcome based on clinical and radiographic criteria was assessed by calibrated examiners and dichotomized as "healed+healing" or "not healed". The age, gender, stage of root development, preoperative signs and symptoms of apical periodontitis and size of periapical lesion were recorded. The effect of potential clinical variables on the treatment outcome of AT was evaluated clinically and radiographically during a 12-48-month follow-up. In order to assess the cumulative successes of CH and MTA after AT, Kaplan-Meier survival analysis and log-rank test was used(p\>0.05).

Eligibility criteria: Inclusion Criteria:

* patients without a systemic disease and compromised immune status
* patients had immature teeth with periapical lesions with or without previous endodontic treatment.

Exclusion Criteria:

* patients with advanced periodontitis (more than 5 mm periodontal attachment and bone loss),
* teeth with contraindications for endodontic treatment (root fracture, unrestorable tooth, replacement resorption or previous surgical endodontic treatment).

Primary outcomes:
measure: The rate of the healing of the periapical lesion
timeFrame: 12 to 48 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Gözde K Demirci
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Faculty of Dentistry
name: Mehmet Emin Kaval
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Pelin Güneri
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Mehmet Kemal Çalışkan
role: STUDY_DIRECTOR
References:
citation: Bonte E, Beslot A, Boukpessi T, Lasfargues JJ. MTA versus Ca(OH)2 in apexification of non-vital immature permanent teeth: a randomized clinical trial comparison. Clin Oral Investig. 2015 Jul;19(6):1381-8. doi: 10.1007/s00784-014-1348-5. Epub 2014 Dec 3.
citation: Damle SG, Bhattal H, Loomba A. Apexification of anterior teeth: a comparative evaluation of mineral trioxide aggregate and calcium hydroxide paste. J Clin Pediatr Dent. 2012 Spring;36(3):263-8.
citation: El-Meligy OA, Avery DR. Comparison of apexification with mineral trioxide aggregate and calcium hydroxide. Pediatr Dent. 2006 May-Jun;28(3):248-53.