Pulpitis - Irreversible
Conditions
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.
Interventions
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.
OTHERTheracal 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.
OTHERTheraCal 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.
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Assessed by Visual Analogue Scale | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORKoray Yılmaz, DDS, MSc, Professor
Cukurova University
Outcome results
None listed