Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- pain, sensitivity to percussion⁄ palpation
研究概览
简要总结
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars.
Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.
详细描述
Diagnosis:
- Full history data will be collected, including personal, medical and previous dental data
- Clinical examination using mirror and probe to assess the inclusion criteria.
- Radiographic examination using preoperative digital periapical radiograph to assess the inclusion criteria.
- Preoperative photograph will be taken.
Operative procedure:
Experimental group:
- Injection of local anesthesia and rubber dam isolation.
- caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.
- The pulps will be amputated to the orifice level using a long-shank diamond round bur.
- Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min.
- Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) will be mixed according to the manufacturer's instructions, radicular pulp will be covered by the material using a wet cotton pellet.
- A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.
- Immediate post-operative radiograph and photograph will be taken.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)
- •Patients with an age range from 7-8 years.
- •Absence of sinus tract, soft tissue swelling.
排除标准
- •• Molars were excluded if non-restorable.
- •excessive mobility (more than 1 mm horizontally).
- •Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄ external root resorption, pulp⁄ canal calcifications.
结局指标
主要结局
pain, sensitivity to percussion⁄ palpation
时间窗: 18 months
by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
Swelling or sinus tract
时间窗: 18 months
by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
tooth mobility
时间窗: 18 months
by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment
次要结局
- root formation/development stage(18 months)
- Crown: Root ratio(18 months)
- Apical closure(18 months)
- presence of radiolucency(18 month)
研究者
Gihan M Abuelniel ,PhD
Associate Professor of Pediatric Dentistry
Cairo University