Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Post operative pain level on visual analogue scale
研究概览
简要总结
Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.
详细描述
Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.
The questionnaire consists of five components:
- Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
- Postoperative complications including postoperative pain, discomfort,or swelling.
These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months. 3. Quality of life instruments designed 4. Semantic scales designed to evaluate patient satisfaction with the treatment received.
Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.
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
- Single (Participant)
盲法说明
Participant will not be informed whether complete pulp removal or partial treatment was done.
Operator and investigator cannot be blinded due to differences in the procedure and it will be evident on the radiographs, so it cannot be masked during radiographic evaluation.
入排标准
- 年龄范围
- 9 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit patient
- •mature permanent tooth with deep caries
- •diagnosis of irreversible pulpits.
- •tooth is restored with a direct restoration
排除标准
- •immature teeth
- •teeth were hemostasis cannot be achieved after pulpotomy
- •necrotic teeth
- •lack of response to cold test
结局指标
主要结局
Post operative pain level on visual analogue scale
时间窗: 7 days
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
Post operative pain level on numerical pain scale
时间窗: 7 days
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
次要结局
- Clinical success(6, 12, 24, 48 months)
- Radiographic success(6, 12, 24, 48 months)