Trials / Completed
CompletedNCT07312539
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 96 (actual)
- Sponsor
- Sümeyra Akkoç · Academic / Other
- Sex
- All
- Age
- 3 Years – 15 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2024-09-27
- Completion
- 2025-02-01
- First posted
- 2025-12-31
- Last updated
- 2025-12-31
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07312539. Inclusion in this directory is not an endorsement.