Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07312539
Enrollment
90
Registered
2025-12-31
Start date
2024-07-01
Completion date
2025-02-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mineral Trioxide Aggregate (MTA), Pulpotomy, Risk Factors, Tooth, Deciduous

Keywords

Pediatric dentistry, Pulpotomy in primary teeth, Restoration quality, Regression analysis, Mineral Trioxide Aggregate

Brief summary

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.

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 152 primary molars from 90 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.

Interventions

None listed

Sponsors

Sümeyra Akkoç
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcomePatients 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 (%).
Radiographic outcomePatients 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 (%).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORŞevval Çakıcı, Assistant Professor, DDS

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

PRINCIPAL_INVESTIGATORBeyza Ecem Alkaç Ekici, Assistant Professor, DDS

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

PRINCIPAL_INVESTIGATORMerve Uluakay, Assistant Professor, DDS

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026