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

NCT03855501 | Completed DMC

• 1 other identifier: 14-12/2
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immature Teeth

Keywords

apexification treatment; calcium hydroxide; mineral trioxide aggregate

Outcome Measures

Primary Outcomes (1)

• The rate of the healing of the periapical lesion

  Follow-up visits were performed 12 to 48 months. Changes in apical bone density was evaluated with the modified PAI radiographic healing criteria. The clinical and radiographic healing classification was as follows: Healed - the tooth was asymptomatic and the radiograph showed PAI 1 or 2 Healing - the tooth was asymptomatic and the radiograph showed PAI 3 or 4, with score improved at follow up from immediate post-treatment radiograph Not healed - the tooth was either symptomatic or the tooth was asymptomatic but the radiograph presented no decrease or an increase in the size of the pre-existing radiolucency at follow up from immediate post-treatment radiograph (PAI 3-5). The treatment outcome was assessed according to the last follow-up data. And all analyses were performed according to the last follow-up data.

  12 to 48 months

Study Arms (2)

Mineral trioxide aggregate

ACTIVE COMPARATOR

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.

Other: Mineral trioxide aggregate

Calcium hydroxide

ACTIVE COMPARATOR

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

Other: Calcium hydroxide

Interventions

Mineral trioxide aggregate OTHER

Apexification treatment was done with mineral trioxide aggregate

Mineral trioxide aggregate

Calcium hydroxide OTHER

Apexification treatment was done with calcium hydroxide

Calcium hydroxide

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ege University: lead

Related Publications (3)

• 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.

  PMID: 25467231 RESULT

• 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.

  PMID: 22838228 RESULT

• El-Meligy OA, Avery DR. Comparison of apexification with mineral trioxide aggregate and calcium hydroxide. Pediatr Dent. 2006 May-Jun;28(3):248-53.

  PMID: 16805357 RESULT

MeSH Terms

Interventions

mineral trioxide aggregate; Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Gözde K Demirci

  Ege University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Mehmet Emin Kaval

  Ege University Faculty of Dentistry

  STUDY CHAIR

• Pelin Güneri

  Ege University Faculty of Dentistry

  STUDY CHAIR

• Mehmet Kemal Çalışkan

  Ege University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share