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Completed

NCT Number: NCT07312539

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

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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University

Kütahya, Center, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. 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 (%).

  2. 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 (%).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sümeyra Akkoç

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

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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