Evaluation of Pulpotomy, Partial Pulpotomy, and Direct Pulp Capping Using Mineral Trioxide Aggregate.

Evaluation of Pulpotomy, Partial Pulpotomy, and Direct Pulp Capping Using Mineral Trioxide Aggregate in Primary Molars. A Randomized Clinical Trial.

A comparative evaluation for three vital pulp therapy techniques in primary molars using the same material (MTA)

Study Overview

• Status: Active, not recruiting
• Conditions: Vital Pulp Therapy in Primary Teeth
• Intervention / Treatment: Procedure: pulp capping with MTA

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Gamasa, Dakahlia Governorate, Egypt, 35516
      • Delta University for Science and Technology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• articipants were cooperative children (4-7 years) with no systemic diseases or relevant allergies. Eligible teeth were restorable primary second molars with deep carious lesions and a diagnosis of reversible pulpitis,

Exclusion Criteria:

• spontaneous pain, edema, fistula, pathological mobility, or percussion sensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct pulp capping; Technique of vital pulp therapy to cap pin point exposure	Procedure: pulp capping with MTA; Capping of the pulp tissue with a biocompatible material (MTA)
Experimental: Partial pulpotomy; Technique of vital pulp therapy to cap widened pulp exposure	Procedure: pulp capping with MTA; Capping of the pulp tissue with a biocompatible material (MTA)
Experimental: Pulpotomy; Technique of vital pulp therapy of capping radicular pulp after removal of coronal pulp	Procedure: pulp capping with MTA; Capping of the pulp tissue with a biocompatible material (MTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous pain	numeric rating scale (presence or abscence of pain) 0 is best result 10 is the worst	12 months
Radiolucency of the periapical or furcation area	measuring tool is x-ray	Follow up for 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of fistula	Visual inspection	12 months
Pathological mobility	Graded clinical by applying pressure by end of mirror	12 months
Sensitivity on percussion	Methods of tapping on surface in clinical examination	12 months
Widening of personal ligament space	Measuring tool is xray	12 months
Internal or e ternal resorption	Measuring tool is xray	12 months

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Dentistry; Endodontics; Pemetrexed; Dental Pulp Capping
• Other Study ID Numbers: DU:025052113

Drug and device information, study documents

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