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

February 26, 2019 updated by: Gözde Kandemir Demirci, Ege University

Delayed Apexification Treatment With MTA and Ca(OH)2 of Non-vital Immature Teeth in Adults: A Prospective Comparative Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Other: Mineral trioxide aggregate
Apexification treatment was done with mineral trioxide aggregate
ACTIVE_COMPARATOR: 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
Other: Calcium hydroxide
Apexification treatment was done with calcium hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of the healing of the periapical lesion
Time Frame: 12 to 48 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Gözde K Demirci, Ege University Faculty of Dentistry
  • Study Chair: Mehmet Emin Kaval, Ege University Faculty of Dentistry
  • Study Chair: Pelin Güneri, Ege University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (ACTUAL)

February 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-12/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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