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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koray Yılmaz, DDS, MSc, Professor | Cukurova University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | Sarıçam | 01250 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39583272 | Background | 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. |
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| ID | Term |
|---|---|
| C086631 | mineral trioxide aggregate |
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| 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. |
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| 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. |
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