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Completed

NCT Number: NCT07660549

TheraCal Materials Versus MTA in Full Pulpotomy

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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