Evaluation Of Laser Versus Conventional Pulpotomies In Mature Molar Teeth With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of healing progress
研究概览
简要总结
this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
详细描述
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
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)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Permanent molar teeth with symptomatic irreversible pulpitis.
- •The patient should be ≥ 16 to 50 years old.
- •Teeth should give positive response to cold testing and clinical diagnosis of SIP with or without periapical rarefaction.
- •Teeth will be selected only if they are restorable.
- •Patient medically healthy and free from systemic diseases. ASA I, II.
- •patients who agreed to participate in the study to attend the control visits.
- •Teeth with periapical index score (PAI) 1 and 2 will be selected
排除标准
- •Teeth with necrotic pulp, resorption or subgingival caries.
- •Teeth with open apices.
- •Medically compromised patients.
- •Pregnant patients.
- •Patients with uncontrollable bleeding from the radicular pulp.
- •Patients with (PAI) score 3-5 will be excluded from the study
结局指标
主要结局
Assessment of healing progress
时间窗: one year
evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. \-
Radiographic assessment of the dentin bridge formation
时间窗: one year
evaluating the dentin bridge formation using periapical radiographs and CBCT
Automated segmentation of the radicular pulp space
时间窗: one year
this will be done using CBCT imaging
Assessment of healing progress
时间窗: one year
evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. \-
Radiographic assessment of the dentin bridge formation
时间窗: one year
evaluating the dentin bridge formation using periapical radiographs and CBCT
Automated segmentation of the radicular pulp space
时间窗: one year
this will be done using CBCT imaging
次要结局
未报告次要终点
研究者
Rana Hegaz
Assistant lecturer ,Endodontics, Department of Conservative Dentistry, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
Alexandria University