Can TheraCal LC and TheraCal PT Match MTA in Full Pulpotomy? A Twelve-Month Randomized Clinical Trial in Permanent Molars With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
MTA Group
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.
干预措施: Mineral Trioxide Aggregate (MTA) (Other)
TheraCal LC Group
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.
干预措施: Theracal LC (Other)
TheraCal PT Group
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.
干预措施: TheraCal PT (Other)
研究者
Kübra Gürler
Principal Investigator
Cukurova University