Dental Caries, Pulp Exposure, Dental, Primary Teeth, Primary Molar Pulpotomy
Conditions
Keywords
Primary teeth Pulpotomy, Primary Molars, Vital Pulp Therapy, Mineral Trioxide Aggregate, Calcium-Enriched Mixture, TheraCal PT, Ferric Sulfate
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPulpotomy
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.
OTHERCalcium-Enriched Mixture (CEM)
Calcium-enriched mixture (CEM) was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
OTHERFerric Sulfate
Ferric sulfate was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
OTHERTheraCal PT
TheraCal PT was used as the pulpotomy material following coronal pulp removal and hemostasis, according to the study protocol.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Due to the distinct physical characteristics of the pulpotomy materials, the operator could not be blinded to treatment allocation. However, participants were unaware of the assigned material, and clinical and radiographic outcomes were independently assessed by two blinded outcome assessors.
Intervention model description
Participants were randomly assigned to one of four parallel treatment groups according to the pulpotomy material used (ferric sulfate, MTA, CEM, or TheraCal PT). Clinical and radiographic outcomes were evaluated over a 12-month follow-up period.
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Turkey (Türkiye)
Outcome results
None listed