Comparative Clinical and Radiographic Evaluation of Different Pulpotomy Materials in Primary Molars

Comparative Evaluation of the Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars: A Randomized Clinical Trial

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.

Inclusion Criteria:

Patient-related criteria

• Children aged 4-9 years.
• Healthy children with no systemic disease.
• No regular medication use.
• No known allergy to the study materials.
• Cooperative patients able to undergo dental treatment.
• Written informed consent obtained from the parent or legal guardian. Tooth-related criteria
• Restorable primary molars with deep carious lesions requiring pulpotomy.
• Clinical signs and symptoms consistent with reversible pulpitis (no spontaneous, lingering, or nocturnal pain).
• No tenderness to percussion or pathological mobility.
• No swelling or sinus tract associated with the study tooth.
• Hemostasis achieved within 5 minutes after coronal pulp amputation.
• No radiographic evidence of internal or external root resorption, furcation or periapical radiolucency, periodontal ligament widening, or pulp calcification.
• At least two-thirds of the root length remaining.

Exclusion Criteria:

• Failure to meet any of the inclusion criteria.
• No pulp exposure or pulp exposure ≤1 mm after complete caries removal.
• Persistent pain during caries removal despite adequate local anesthesia, suggestive of advanced pulpal inflammation.
• Excessive pulpal bleeding that could not be controlled within 5 minutes.
• Presence of purulent exudate from the pulp.
• Loss of patient cooperation during treatment.
• Withdrawal of parental consent or inability to attend follow-up visits.