TheraCal Materials Versus MTA in Full Pulpotomy

June 22, 2026 updated by: Kübra Gürler, Cukurova University

Can TheraCal LC and TheraCal PT Match MTA in Full Pulpotomy? A Twelve-Month Randomized Clinical Trial in Permanent Molars With Symptomatic Irreversible Pulpitis

The goal of this randomized clinical trial is to compare the clinical performance of three pulp capping materials used in full pulpotomy procedures in mature mandibular molars with symptomatic irreversible pulpitis.

The main questions it aims to answer are:

  • Does full pulpotomy using mineral trioxide aggregate (MTA) provide favorable postoperative pain control and 12-month clinical success?
  • Does full pulpotomy using TheraCal LC provide comparable postoperative pain control and 12-month clinical success to MTA?
  • Does full pulpotomy using TheraCal PT provide comparable postoperative pain control and 12-month clinical success to MTA?

Participants will undergo full pulpotomy treatment in mandibular first or second molars diagnosed with symptomatic irreversible pulpitis. After removal of the coronal pulp tissue and achievement of hemostasis, teeth will be randomly assigned to one of three treatment groups.

In the MTA group, the exposed radicular pulp tissue will be covered with mineral trioxide aggregate.

In the TheraCal LC group, the exposed radicular pulp tissue will be covered with light-cured resin-modified calcium silicate material.

In the TheraCal PT group, the exposed radicular pulp tissue will be covered with dual-cured resin-modified calcium silicate material.

Postoperative pain intensity, analgesic intake, and 12-month clinical outcomes will be compared among the three groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Sarıçam
      • Adana, Sarıçam, Turkey (Türkiye), 01250
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients requiring full pulpotomy treatment in mandibular first or second permanent molars diagnosed with symptomatic irreversible pulpitis.
  • Mandibular first or second permanent molars with a preoperative Visual Analogue Scale (VAS) pain score ≥4, indicating moderate or severe pain.
  • Vital mandibular first or second permanent molars showing positive responses to both cold and electric pulp tests.
  • Teeth with deep carious lesions indicated for vital pulp therapy.
  • Teeth with no radiographic evidence of periapical pathology.
  • Patients who had not taken analgesics or antibiotics within the 24 hours preceding the procedure.

Exclusion Criteria:

  • Non-vital mandibular permanent molars showing negative responses to cold or electric pulp tests.
  • Non-restorable teeth.
  • Teeth with root caries, open apex, pulp calcification, internal or external resorption, or periodontal involvement.
  • Mandibular first or second permanent molars with poor periodontal status, defined as periodontal pocket depth >4 mm.
  • Teeth with radiographic evidence of periapical pathology.
  • Patients with systemic conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, chronic kidney disease, hematological disorders, or a history of chemotherapy or radiotherapy.
  • Patients with contraindications to full pulpotomy treatment or local anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MTA Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate (MTA). The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed. A moist sterile cotton pellet was then placed over the material for approximately 10 minutes to allow initial setting. The tooth was subsequently restored using a standardized restorative protocol.
Other: Mineral Trioxide Aggregate (MTA)
In the MTA group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with mineral trioxide aggregate. The material was placed over the pulp surface at a thickness of approximately 2-4 mm and gently condensed.
Experimental: TheraCal LC Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm to ensure adequate polymerization. Each increment was light-cured for 20 seconds, and the total material thickness was approximately 2-3 mm. The tooth was subsequently restored using a standardized restorative protocol.
Other: Theracal LC
In the TheraCal LC group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal LC, a light-cured resin-modified calcium silicate material. The material was applied in increments not exceeding 1 mm, and each increment was light-cured for 20 seconds.
Experimental: TheraCal PT Group
After removal of the coronal pulp tissue and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds using an LED curing unit. The tooth was subsequently restored using a standardized restorative protocol.
Other: TheraCal PT
In the TheraCal PT group, after full pulpotomy and achievement of hemostasis, the exposed radicular pulp tissue was covered with TheraCal PT, a dual-cured resin-modified calcium silicate material. The material was applied as a single layer at a thickness of approximately 2-3 mm and light-cured for 20 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Time Frame: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment
Postoperative pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will record their pain intensity at predetermined postoperative time points after full pulpotomy treatment. VAS scores will be compared among the MTA, TheraCal LC, and TheraCal PT groups.
Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Koray Yılmaz, DDS, MSc, Professor, Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

April 6, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.12.2024/16

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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