Treatment Outcomes of Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- "Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
研究概览
简要总结
The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment. The researchers will compare the clinical success of Biodentine and Theracal PT dental filling materials with each other.
Participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient age should be between 18-50 years
- •Should be able to give written informed consent
- •Should have systemic status (ASA 1)
- •Should have permanent molar or premolar (lower and upper) root development
- •Should be asymptomatic, deep (D3) or extremely deep (D4) caries
- •Should give vital response in cold test and electric pulp test
- •Should have teeth where the pulp is exposed with caries
- •Should not have pain during palpation and percussion
- •Should not have periodontal disease
- •Should have restorable teeth
- •Should have teeth without pulp necrosis, sinus tract or swelling/abscess
- •Should have bleeding time less than 10 minutes
- •Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)
排除标准
- •Teeth with incomplete root development
- •Severely affected teeth that do not respond to pulp sensitivity tests
- •Teeth with signs and symptoms of irreversible pulpitis
- •Teeth without signs of bleeding after communicating with the pulp chamber
- •Teeth with pulp chamber open to the oral environment
- •Teeth with periodontal pockets greater than 4 mm deep
- •Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
- •Teeth with uncontrolled bleeding
- •Medically at-risk patients will be excluded from the study.
研究组 & 干预措施
Partial Pulpotomy with Biodentine
干预措施: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) (Device)
Partial Pulpotomy with Theracal PT
干预措施: Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA) (Device)
结局指标
主要结局
"Tooth survival". Both clinical and radiographic healing means "Tooth survival". Clinical healing; absence of clinical symptoms. Radiographic healing; absence of emerging periapical radiolucency.
时间窗: From enrollment to the end of treatment at 1 year
次要结局
- "Post operative pain". It will be evaluated with a 10-unit visual analog scale. 0: no pain, 1-3 mild pain, 4-6 moderate-severe pain, 7-9 very severe pain, 10 worst pain.(From enrollment to the follow up at 1 week, 3,6.12 months")
研究者
Tuba Gök
PhD., Assistant Professor
Firat University