TheraCal Materials Versus MTA in Full Pulpotomy (NCT07660549) | Clinical Trial Compass
CompletedNot Applicable
TheraCal Materials Versus MTA in Full Pulpotomy
Turkey (Türkiye)72 participantsStarted 2024-12-16
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Intensity Assessed by Visual Analogue Scale
Timeframe: Preoperative baseline, 24 hours, 72 hours, 7 days, and 14 days after treatment