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

Immature Teeth Clinical Trial

— MTA 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855501
• Other study ID #: 14-12/2
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Immature Teeth

Intervention

Other:
• Mineral trioxide aggregate
Apexification treatment was done with mineral trioxide aggregate
• Calcium hydroxide
Apexification treatment was done with calcium hydroxide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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