Clinical and Radiographic Comparison of Indirect Pulp Treatment and Direct Pulp Capping in Deep Carious Primary Second Molars: One-Year Results
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Clinical success of indirect pulp treatment and direct pulp capping
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Indirect Pulp Treatment (IPT)
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).
Intervention: Indirect Pulp Treatment (Procedure)
Direct Pulp Capping (DPC)
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).
Intervention: Direct Pulp Capping (Procedure)
Outcomes
Primary Outcomes
Clinical success of indirect pulp treatment and direct pulp capping
Time Frame: 12 months
Clinical success was defined as the absence of spontaneous pain, swelling, fistula, pathological mobility, or tenderness to percussion.
Radiographic success of indirect pulp treatment and direct pulp capping
Time Frame: 12 months
Radiographic success was defined as the absence of periapical radiolucency, internal or external root resorption, pathological changes, or other radiographic signs of pulpal or periapical pathology during the follow-up period.
Secondary Outcomes
- Effect of pulp exposure location on treatment success(12 months)
Investigators
Ozlem Beren SATILMIS
Principal Investigator
Ankara University