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Completed

NCT Number: NCT03855501

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

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.

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Key information

Conditions

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mineral trioxide aggregate

Other

Apexification treatment was done with mineral trioxide aggregate

Calcium hydroxide

Other

Apexification treatment was done with calcium hydroxide

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Acronym: MTA Ca(OH)2

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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