TheraCal Materials Versus MTA in Full Pulpotomy

NCT07660549 | Completed DMC

• 1 other identifier: 06.12.2024/16
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Assessed by Visual Analogue Scale

  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

Study Arms (3)

MTA Group

ACTIVE COMPARATOR

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)

TheraCal LC Group

EXPERIMENTAL

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

TheraCal PT Group

EXPERIMENTAL

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

Interventions

Mineral Trioxide Aggregate (MTA) OTHER

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.

MTA Group

Theracal LC OTHER

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.

TheraCal LC Group

TheraCal PT OTHER

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.

TheraCal PT Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (1)

• Gilhotra V, Kumar T, Mittal S, Keshav V, Maakhni E, Kesarwani D. Comparative evaluation of various biomaterials as pulpotomy agents in molars with symptomatic irreversible pulpitis: A randomized single-blinded single-center control trial. J Conserv Dent Endod. 2024 Oct;27(10):1065-1072. doi: 10.4103/JCDE.JCDE_446_24. Epub 2024 Oct 5.

  PMID: 39583272 BACKGROUND

MeSH Terms

Interventions

mineral trioxide aggregate

Study Officials

• Koray Yılmaz, DDS, MSc, Professor

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: December 16, 2024
• Primary Completion: June 18, 2025
• Study Completion: April 6, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)