Indirect and Direct Pulp Therapy in Primary Second Molars

NCT07382115 | Completed

• 1 other identifier: 07/07
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Clinical success of indirect pulp treatment and direct pulp capping

  Clinical success was defined as the absence of spontaneous pain, swelling, fistula, pathological mobility, or tenderness to percussion.

  12 months

• Radiographic success of indirect pulp treatment and direct pulp capping

  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.

  12 months

Secondary Outcomes (1)

• Effect of pulp exposure location on treatment success

  12 months

Study Arms (2)

Indirect Pulp Treatment (IPT)

EXPERIMENTAL

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).

Procedure: Indirect Pulp Treatment

Direct Pulp Capping (DPC)

EXPERIMENTAL

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).

Procedure: Direct Pulp Capping

Interventions

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).

Indirect Pulp Treatment (IPT)

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).

Direct Pulp Capping (DPC)

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: April 30, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)