Tooth, DeciduousNCT07312539
Risk Factors on the Long-Term Success of Mineral Trioxide Aggregate Pulpotomy
An observational study of Tooth, Deciduous and Pulpotomy, run by Sümeyra Akkoç at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Deciduous, Pulpotomy, Risk Factors
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Feb 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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. 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.
Who may be able to join
- 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 ++)
Who cannot join
- Teeth that had exfoliated or received treatment at another center during the follow-up period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
Kütahya, Center, 43100
About this study
Official title: 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.
Read the 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.
- Keywords
- Pediatric dentistry, Pulpotomy in primary teeth, Restoration quality, Regression analysis, Mineral Trioxide Aggregate
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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 (%).
Measured: Patients were recalled for evaluation at 24 months post-treatment; follow-up was complete when the last enrolled patient attended the 24-month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jul 2024
- Primary completion27 Sep 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth, DeciduousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sümeyra Akkoç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyra Akkoç, Kutahya Health Sciences University
- Investigators
- Şevval Çakıcı, Assistant Professor, DDS, Principal investigator, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences UniversityBeyza Ecem Alkaç Ekici, Assistant Professor, DDS, Principal investigator, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences UniversityMerve Uluakay, Assistant Professor, DDS, Principal investigator, Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312539
- Sponsor's protocol ID
- 2024/08-27
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18402097Hickel 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.
PubMed 20628774Kim 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.
PubMed 32754786Yu 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.
PubMed 38755981An 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.
PubMed 38239160
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Potential Risk Factors on the Long-Term Success of Mineral Trioxide Aggregate Pulpotomy in Primary Teeth
- ClinicalTrials.gov ID
- NCT07312539
- Acronym / sponsor ID
- 2024/08-27
- Keywords
- Pediatric dentistry, Pulpotomy in primary teeth, Restoration quality, Regression analysis, Mineral Trioxide Aggregate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sümeyra AkkoçUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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. 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Teeth that had exfoliated or received treatment at another center during the follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 (%).
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 (%).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 18402097Zurn 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.
- Results publication: PubMed 20628774Hickel 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.
- Results publication: PubMed 32754786Kim 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.
- Results publication: PubMed 38755981Yu 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.
- Results publication: PubMed 38239160An 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Tooth, Deciduous
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şevval Çakıcı, Assistant Professor, DDS principal investigator
Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
Beyza Ecem Alkaç Ekici, Assistant Professor, DDS principal investigator
Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
Merve Uluakay, Assistant Professor, DDS principal investigator
Department of Pediatric Dentistry, Faculty of Dentistry, Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth, Deciduous and Pulpotomy, run by Sümeyra Akkoç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312539, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.