Treatment Outcomes of Full Pulpotomy Using Two Different Calcium Silicate-based Materials in Mature Permanent Teeth With Irreversible Pulpitis Symptoms: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 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 NeoPutty dental filling materials are in treating dental pulp inflammation in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and NeoPutty dental filling materials treat dental pulpitis in participants? Do they reduce the need for root canal treatment?
After the application of Biodentine and NeoPutty 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 NeoPutty dental filling materials with each other.
Participants will undergo a single-session 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 must be between 18-50 years
- •Must be able to give written informed consent
- •Must have systemic status (ASA 1)
- •Must have mature permanent molar or premolar (lower upper)
- •Must be symptomatic (spontaneous pain - mild to severe), extremely deep (D4) carious teeth
- •Must have pulp exposure in non-selective carious cleaning procedure
- •Must have vital response in cold test and electric pulp test
- •Must have no periodontal disease
- •Must have restorable teeth
- •Must have teeth without pulp necrosis, sinus tract or swelling/abscess
- •Must have bleeding time less than 10 minutes
- •Maximum two teeth in a patient must be included in the study (must be in different quadrants and must have at least 2 weeks between treatment periods)
排除标准
- •Teeth with incomplete root development
- •Teeth without symptoms of irreversible pulpitis
- •Severely affected teeth that do not respond to pulp sensitivity tests
- •Teeth without signs of bleeding after exposure 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 risky patients will be excluded from the study.
研究组 & 干预措施
Total Pulpotomy with Biodentine
干预措施: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) (Device)
Total Pulpotomy with NeoPutty
干预措施: NeoPutty (calcium silicate-based cement) (Avalon Biomed, Bradenton, 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