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

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 Overview

• Status: Completed
• Conditions: Deep Dentin Caries in Primary Teeth; Pulp Therapy in Primary Molars
• Intervention / Treatment: Procedure: Indirect Pulp Treatment; Procedure: Direct Pulp Capping

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye)
      • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: Indirect Pulp Treatment; 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).
Experimental: 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).	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of pulp exposure location on treatment success	The location of pulp exposure (occlusal or proximal) was recorded and its association with clinical and radiographic success of vital pulp therapy was evaluated.	12 months

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; indirect pulp treatment; direct pulp capping; Mineral trioxide aggregate; Primary second molars
• Other Study ID Numbers: 07/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No