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

NCT07312539 | Completed

• 1 other identifier: 2024/08-27
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Clinical outcome

  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

  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 Outcomes (1)

• Potential risk factors associated with treatment failure

  Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 ++)

You may not qualify if:

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

Sponsors & Collaborators

• Sümeyra Akkoç: lead

Study Sites (1)

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

Kütahya, Center, 43100, Turkey (Türkiye)

Location

Related Publications (5)

• Zurn D, Seale NS. Light-cured calcium hydroxide vs formocresol in human primary molar pulpotomies: a randomized controlled trial. Pediatr Dent. 2008 Jan-Feb;30(1):34-41.

  PMID: 18402097 RESULT

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

  PMID: 20628774 RESULT

• Kim CH, Bae JS, Kim IH, Song JS, Choi HJ, Kang CM. Prognostic factors for the survival of primary molars following pulpotomy with mineral trioxide aggregate: a retrospective cohort study. Clin Oral Investig. 2021 Apr;25(4):1797-1804. doi: 10.1007/s00784-020-03482-3. Epub 2020 Aug 4.

  PMID: 32754786 RESULT

• Yu Y, Hao S, Jin Y, Zhang Q, Wang Y, Zou J. Potential factors affecting the success rate of indirect pulp therapy in primary molars with deep caries: a retrospective study. J Clin Pediatr Dent. 2024 May;48(3):46-51. doi: 10.22514/jocpd.2024.058. Epub 2024 May 3.

  PMID: 38755981 RESULT

• An Y, Ferretti M, Bresler R, Pham E, Ferretti GA. Biodentine as a pulpotomy medicament for primary molars: a retrospective chart review. J Clin Pediatr Dent. 2024 Jan;48(1):85-90. doi: 10.22514/jocpd.2024.011. Epub 2024 Jan 3.

  PMID: 38239160 RESULT

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, DDS

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 31, 2025
• Study Start: July 1, 2024
• Primary Completion: September 27, 2024
• Study Completion: February 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)