An interventional study of Pulpotomy and Mineral Trioxide Aggregate (MTA) in Dental Caries, Pulp Exposure, Dental and Primary Teeth, sponsored by Inonu University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Inonu University · Not applicable, Interventional, and Treatment
Among 128 studies in Dental Caries with a site in Turkey — 24 open to participants now, 41 under way, none of them phase 3. Dental Caries · Turkey.
Among the 128 studies in Dental Caries with a site in Turkey, this one is the 13th largest by enrollment of the 95 interventional ones, is one of 10 that started in 2021, is one of 92 with no phase, and was the 119th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 140 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →24 of the 128 studies in Dental Caries with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 4 Years to 9 Years · all sexes · no healthy volunteers.
The full table on the hub →128 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 10 started in 2021.
Median enrollment 60 across the 95 interventional studies, 90 across the 33 observational. Of the 77 that completed or were terminated, 1 (1%) have results posted.
None of the 128 has an industry lead sponsor. The 10 most frequent:
Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.
Inonu University has 1 study filed under Dental Caries — fewer than ten, so there is no comparison to draw.
12 of the studies in Dental Caries with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07846098Cumhuriyet UniversityComparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars | 2026-11-20 |
| NCT07431463Izmir Katip Celebi UniversityEffects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial | 2026-11-30 |
| NCT07673952Hacettepe UniversityEffect on Placement Tecnique of Bulkfill Composite | 2027-01-01 |
| NCT07609797Gül KeskinThe Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries | 2027-01-01 |
| NCT07548008Marmara UniversityFerric Sulfate and Sodium Hypochlorite Pulpotomies in Vital Primary Teeth | 2027-02-10 |
Among the 128 studies in Dental Caries with a site in Turkey, from their registry updates:
This randomized clinical trial compared the clinical and radiographic outcomes of ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to four treatment groups. Clinical and radiographic evaluations were performed at 3, 6, 9, and 12 months to compare treatment success and failure among the four pulpotomy materials.
Vital pulpotomy is a well-established treatment for preserving the vitality of primary molars with carious pulp exposure when the radicular pulp is considered healthy. Several pulpotomy materials have been proposed, including ferric sulfate (FS), mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM), and TheraCal PT. Although FS, MTA, and CEM have been extensively investigated, clinical evidence regarding the performance of TheraCal PT in primary molar pulpotomy remains limited.
This study was designed as a single-center, parallel-group, randomized controlled clinical trial to compare the clinical and radiographic outcomes of FS, MTA, CEM, and TheraCal PT used for pulpotomy in primary molars. A total of 140 restorable primary molars from children aged 4 to 9 years were randomly allocated to one of four treatment groups. Following pulpotomy, all teeth were restored according to the study protocol and evaluated clinically and radiographically at 3, 6, 9, and 12 months.
The primary outcome measure was the 12-month clinical and radiographic success of pulpotomy. Secondary outcomes included treatment failure patterns and the influence of tooth type, arch, and restoration type on treatment success.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient-related criteria
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mineral Trioxide Aggregate
Procedure: Pulpotomy · Other: Mineral Trioxide Aggregate (MTA)
Calcium-Enriched Mixture (CEM)
Procedure: Pulpotomy · Other: Calcium-Enriched Mixture (CEM)
Ferric Sulfate
Procedure: Pulpotomy · Other: Ferric Sulfate
TheraCal PT
Procedure: Pulpotomy · Other: TheraCal PT
Pulpotomy is a vital pulp therapy procedure in which the coronal pulp tissue is removed while preserving the vitality of the radicular pulp. Following hemostasis, the assigned pulpotomy material was applied according to the study protocol before definitive restoration of the tooth.
Mineral trioxide aggregate (MTA) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Rate of clinical success at 12 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 12-month follow-up.
Time frame: 12 months
Rate of radiographic success at 12 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 12-month follow-up.
Time frame: 12 months
Rate of clinical success at 3 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 3-month follow-up.
Time frame: 3 months
Rate of clinical success at 6 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 6-month follow-up.
Time frame: 6 months
Rate of clinical success at 9 months
Clinical success was defined as the absence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars meeting all clinical success criteria at the 9-month follow-up.
Time frame: 9 months
Rate of radiographic success at 3 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 3-month follow-up.
Time frame: 3 months
Rate of radiographic success at 6 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 6-month follow-up.
Time frame: 6 months
Rate of radiographic success at 9 months
Radiographic success was defined as the absence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars meeting all radiographic success criteria at the 9-month follow-up.
Time frame: 9 months
Rate of clinical failure patterns at 12 months
Clinical failure patterns included spontaneous pain, tenderness to percussion, pathological mobility, swelling, and sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars exhibiting each clinical failure pattern at the 12-month follow-up.
Time frame: 12 months
Rate of radiographic failure patterns at 12 months
Radiographic failure patterns included periodontal ligament widening, internal or external root resorption, furcation radiolucency, and periapical radiolucency. The outcome will be reported as the percentage of treated primary molars exhibiting each radiographic failure pattern at the 12-month follow-up.
Time frame: 12 months
Rate of clinical treatment failure according to tooth type at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to tooth type (first or second primary molar).
Time frame: 12 months
Rate of radiographic treatment failure according to tooth type at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to tooth type (first or second primary molar).
Time frame: 12 months
Rate of clinical treatment failure according to dental arch at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to dental arch (maxillary or mandibular).
Time frame: 12 months
Rate of radiographic treatment failure according to dental arch at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to dental arch (maxillary or mandibular).
Time frame: 12 months
Rate of clinical treatment failure according to restoration type at 12 months
Clinical treatment failure was defined as the presence of spontaneous pain, tenderness to percussion, pathological mobility, swelling, or sinus tract/fistula. The outcome will be reported as the percentage of treated primary molars with clinical treatment failure according to restoration type (stainless steel crown or composite resin restoration).
Time frame: 12 months
Rate of radiographic treatment failure according to restoration type at 12 months
Radiographic treatment failure was defined as the presence of periodontal ligament widening, internal or external root resorption, furcation radiolucency, or periapical radiolucency. The outcome will be reported as the percentage of treated primary molars with radiographic treatment failure according to restoration type (stainless steel crown or composite resin restoration).
Time frame: 12 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author. The study protocol and statistical analysis plan will also be available. Data will be shared for the purpose of scientific research after publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months following publication and ending 5 years after publication.
Access criteria: Access will be provided to researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Shared data will be de-identified to protect participant confidentiality.
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Oct 2022, 12 months.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 12 months is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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