Apexification Treatment With MTA(Mineral Trioxide Aggregate) and Ca(OH)2 (MTA Ca(OH)2)

Ege University

Status: Completed

Conditions: Immature Teeth

Treatments: Other: Mineral trioxide aggregate; Other: Calcium hydroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03855501

14-12/2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Mineral trioxide aggregate

Active Comparator group

Description:

The root canals were gently instrumented with K-files and copious irrigation was done with 2.5% sodium hypochlorite(NaOCI) by means of a 30 gauge endodontic irrigating needle . After drying with large sterile paper points, calcium hydroxide(CH) paste was mixed with saline and applied to the root canal with a lentulo spiral filler at low speed. A cotton pellet was used to gently compress CH into the root canal and its placement was examined radiographically before placing ZOE as temporary restoration into the access cavity. After one week, CH was removed from the canal by using both the files and the irrigation with 2.5% NaOCI and 17% ethylenediaminetetraacetic acid (EDTA). A final irrigation was made with 2% chlorhexidine (CHX) before obturation. Following drying the root canal with sterile paper points, MTA was placed with a MTA Endo Gun into the apical portion of canals with a minimum 4-mm thickness and adapted to the canal walls with an endodontic hand plugger.

Treatment:

Other: Mineral trioxide aggregate

Calcium hydroxide

Active Comparator group

Description:

After using the same biomechanical root canal preparation protocol, the root canal was filled to working length with CH paste. Both clinical and radiographical examinations were performed to evaluate the barrier formation and periapical healing. When a continuous hard tissue barrier was observed apically on radiographs that was verified by clinical probing and complete or significant periapical healing was noticed, the root canal was obturated and coronary restorations were completed as done in MTA group

Treatment:

Other: Calcium hydroxide