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

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.

• Pulpotomy (Procedure): 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) (Other): 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) (Other): Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
• Ferric Sulfate (Other): Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
• TheraCal PT (Other): TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.

Primary outcomes

• Rate of clinical success at 12 months [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.
• Rate of radiographic success at 12 months [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.

Secondary outcomes

• Rate of clinical success at 3 months [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.
• Rate of clinical success at 6 months [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.
• Rate of clinical success at 9 months [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.
• Rate of radiographic success at 3 months [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.
• Rate of radiographic success at 6 months [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.
• Rate of radiographic success at 9 months [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.
• Rate of clinical failure patterns at 12 months [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.
• Rate of radiographic failure patterns at 12 months [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.
• Rate of clinical treatment failure according to tooth type at 12 months [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).
• Rate of radiographic treatment failure according to tooth type at 12 months [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).
• Rate of clinical treatment failure according to dental arch at 12 months [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).
• Rate of radiographic treatment failure according to dental arch at 12 months [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).
• Rate of clinical treatment failure according to restoration type at 12 months [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).
• Rate of radiographic treatment failure according to restoration type at 12 months [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).

Sex: All, ages: 4 Years to 9 Years

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.