Risk Factors on the Long-Term Success of Mineral Trioxide Aggregate Pulpotomy

December 16, 2025 updated by: Sümeyra Akkoç

The Influence of Potential Risk Factors on the Long-Term Success of Mineral Trioxide Aggregate Pulpotomy in Primary Teeth

The goal of this observational study is to learn about the long-term results of Mineral Trioxide Aggregate (MTA) pulpotomy in primary molars and the factors that may affect treatment success.

The main question it aims to answer is:

Do clinical, operator and restoration-related factors influence the long-term success of MTA pulpotomy in primary molars?

In this study, children who received MTA pulpotomy treatment were examined at the 24-month follow-up visit, scheduled at the beginning of the study. Two examiners checked the clinical condition of the teeth, and two other examiners reviewed the radiographs without knowing the clinical results.

Study Overview

Status

Completed

Conditions

Detailed Description

This cross-sectional observational study was conducted to evaluate the 24-month clinical and radiographic outcomes of Mineral Trioxide Aggregate (MTA) pulpotomy in primary molars and to identify potential risk factors associated with treatment failure. The study included 175 primary molars from 96 children who met the inclusion criteria and were invited to the 24-month follow-up visit scheduled at the beginning of the study. At this visit, two clinical examiners assessed the clinical condition of the teeth, and two radiographic examiners, blinded to the clinical data, evaluated the radiographic outcomes.

Clinical and radiographic findings were scored based on criteria originally established by Zurn and Seale, subsequently adapted by Rajasekharan et al., and recently by Cordell et al. The risk factors that could have influenced treatment failure were also documented, including arch type (maxillary or mandibular), tooth type (first or second primary molar), side (right or left), number of restored surfaces, and restoration quality. Restoration quality was assessed using the modified FDI criteria assessing esthetic, functional, and biological properties.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Center
      • Kütahya, Center, Turkey (Türkiye), 43100
        • Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University

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

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of patients aged 3 to 15 years at the time of treatment, who received pulpotomy treatment using MTA in at least one primary molar between July 1 and November 1, 2022. To evaluate the treatment outcomes and potential risk factors for treatment failure, follow-up appointments were scheduled 24 months after the pulpotomy procedure, and patients were invited to attend at that time in accordance with the order of patient registration.

Description

Inclusion Criteria:

  • Systemically healthy children
  • Complete preoperative clinical and radiographic records available
  • No additional treatment performed on the treated tooth after the initial MTA pulpotomy
  • Attendance at the 24-month follow-up appointment
  • Willingness to participate in the study
  • Positive or definitely positive behavior during the clinical examination at the 24-month follow-up visit (Frankl Behavior Rating Scale: + or ++)

Exclusion Criteria:

  • Teeth that had exfoliated or received treatment at another center during the follow-up period

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.
Clinical outcome was evaluated at 24 months post-treatment by clinical examination using the standardized criteria defined by Zurn and Seale. Scores of 1-2 were classified as treatment success and scores of 3-4 as treatment failure, and results were reported as the proportion of teeth with clinical success (%).
Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.
Radiographic outcome
Time Frame: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.
Radiographic outcome was evaluated at 24 months post-treatment by clinical examination using the standardized criteria defined by Zurn and Seale. Scores of 1-2 were classified as treatment success and scores of 3-4 as treatment failure, and results were reported as the proportion of teeth with clinical success (%).
Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential risk factors associated with treatment failure
Time Frame: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.
Treatment outcome (success vs failure) was analyzed using binary logistic regression with prespecified predictors including arch type (maxillary/mandibular), tooth type (first/second primary molar), side (right/left), number of restored surfaces, operator, and restoration quality. Results were reported as adjusted odds ratios (ORs) with 95% confidence intervals.
Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.

Collaborators and Investigators

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

Sponsor

Sümeyra Akkoç

Investigators

  • Principal Investigator: Şevval Çakıcı, Assistant Professor, DDS, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
  • Principal Investigator: Beyza Ecem Alkaç Ekici, Assistant Professor, DDS, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
  • Principal Investigator: Merve Uluakay, Assistant Professor, DDS, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University

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)

July 1, 2024

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/08-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and analyzed during the current study are not publicly available due to privacy or ethical restrictions but are available from the corresponding author on reasonable request.

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.

Clinical Trials on Risk Factors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe