Indirect and Direct Pulp Therapy in Primary Second Molars

Ankara University

Status: Completed

Conditions: Pulp Therapy in Primary Molars; Deep Dentin Caries in Primary Teeth

Treatments: Procedure: Direct Pulp Capping; Procedure: Indirect Pulp Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07382115

07/07

Details and patient eligibility

About

The purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Children with deep dentin caries in primary molars were randomly assigned to receive either IPT or DPC. Clinical and radiographic evaluations were performed at 6 and 12 months to assess treatment success. The findings of this study aim to provide evidence-based guidance for the management of deep dentin caries in primary teeth.

Enrollment: 45 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Systemically healthy children aged 7 to 9 years
• Primary second molars with deep dentin caries indicated for vital pulp therapy
• Absence of clinical signs or symptoms of irreversible pulpitis
• No spontaneous or prolonged pain
• Teeth with no tenderness to percussion or palpation
• No pathological mobility, swelling, fistula, or abscess
• Radiographic findings showing intact lamina dura and normal periodontal ligament space
• Absence of periapical or furcation radiolucency
• No evidence of pathological internal or external root resorption
• Teeth considered restorable
• Written informed consent obtained from parents

Exclusion criteria

• Children with systemic diseases or medical conditions affecting healing
• Teeth with signs or symptoms of irreversible pulpitis
• Presence of spontaneous pain, night pain, or prolonged pain
• Teeth with periapical or furcation radiolucency
• Teeth with pathological internal or external root resorption
• Presence of pulpal calcifications or pulp stones
• Non-restorable teeth
• Lack of parental consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Indirect Pulp Treatment (IPT)

Experimental group

Description:

Teeth allocated to this arm received indirect pulp treatment. Selective caries removal was performed, leaving affected dentin over the pulp, followed by placement of mineral trioxide aggregate (MTA) and restoration with a stainless steel crown (SSC).

Treatment:

Procedure: Indirect Pulp Treatment

Direct Pulp Capping (DPC)

Experimental group

Description:

Teeth allocated to this arm received direct pulp capping. After \<1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC).

Treatment:

Procedure: Direct Pulp Capping