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

NCT ID: NCT03855501

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-02-28

Brief Summary

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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

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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).

Conditions

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Immature Teeth

Keywords

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apexification treatment calcium hydroxide mineral trioxide aggregate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mineral trioxide aggregate

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.

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate

Intervention Type OTHER

Apexification treatment was done with mineral trioxide aggregate

Calcium hydroxide

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

Group Type ACTIVE_COMPARATOR

Calcium hydroxide

Intervention Type OTHER

Apexification treatment was done with calcium hydroxide

Interventions

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Mineral trioxide aggregate

Apexification treatment was done with mineral trioxide aggregate

Intervention Type OTHER

Calcium hydroxide

Apexification treatment was done with calcium hydroxide

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gözde Kandemir Demirci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gözde K Demirci

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Dentistry

Mehmet Emin Kaval

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Pelin Güneri

Role: STUDY_CHAIR

Ege University Faculty of Dentistry

Mehmet Kemal Çalışkan

Role: STUDY_DIRECTOR

Ege University Faculty of Dentistry

References

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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.

Reference Type RESULT
PMID: 25467231 (View on PubMed)

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.

Reference Type RESULT
PMID: 22838228 (View on PubMed)

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

Reference Type RESULT
PMID: 16805357 (View on PubMed)

Other Identifiers

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14-12/2

Identifier Type: -

Identifier Source: org_study_id