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
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.
Patient-related criteria
Exclusion Criteria:
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, Sap
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Inonu University