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Indirect and Direct Pulp Therapy in Primary Second Molars

Clinical and Radiographic Comparison of Indirect Pulp Treatment and Direct Pulp Capping in Deep Carious Primary Second Molars: One-Year Results

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07382115
Enrollment
45
Registered
2026-02-02
Start date
2019-04-30
Completion date
2020-04-30
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Dentin Caries in Primary Teeth, Pulp Therapy in Primary Molars

Keywords

indirect pulp treatment, direct pulp capping, Mineral trioxide aggregate, Randomized controlled trial, Primary second molars

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.

Interventions

Selective caries removal was performed, leaving affected dentin over the pulp. Mineral trioxide aggregate (MTA) was placed, followed by restoration with a stainless steel crown (SSC).

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).

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical success of indirect pulp treatment and direct pulp capping12 monthsClinical 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 capping12 monthsRadiographic 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

MeasureTime frameDescription
Effect of pulp exposure location on treatment success12 monthsThe location of pulp exposure (occlusal or proximal) was recorded and its association with clinical and radiographic success of vital pulp therapy was evaluated.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026