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NCT Number: NCT07382115

Indirect and Direct Pulp Therapy in Primary Second Molars

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.

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Key information

Conditions

Deep Dentin Caries in Primary Teeth Pulp Therapy in Primary Molars

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indirect Pulp Treatment

Procedure

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).

direct pulp capping

Procedure

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).

Primary outcomes

  1. 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.

  2. 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

  1. Effect of pulp exposure location on treatment success

    Time frame: 12 months

    The location of pulp exposure (occlusal or proximal) was recorded and its association with clinical and radiographic success of vital pulp therapy was evaluated.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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