Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- presence of 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) preserving the vitality of traumatized immature anterior permanent teeth.
Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth 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 analyzed.
详细描述
Informed consent was obtained from all patients prior to treatment, and patients were offered Root canal treatment in case of treatment failure.
Thirty-three patients who were referred to the postgraduate pediatric dentistry department clinic for the management of their traumatized permanent incisors teeth were assessed. Only Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical signs/symptoms) were included.
Incisors were assigned randomly in the two groups. The MTA group was considered the control group while the biodentine was the test group.
All patients who were clinically eligible for enrollment in the study went through screening pre-operative digital periapical radiographic examination to assess the degree of root development/ formation and any dental infections or anomalies that could interfere with the planned treatment.
The main investigator performed all pulpotomies. Local anesthesia was administrated followed by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered with:
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)
盲法说明
Patients and their parents, the assessor and the statistician will be blinded.
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient age range 7.5-9 years.
- •Noncontributory medical history
- •Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm)
- •The tooth should give positive response to cold testing
- •Clinical diagnosis of reversible pulpitis without periapical rarefaction
- •The tooth is restorable, mobility was within normal limits
- •No signs of pulpal necrosis including sinus tract or swelling
排除标准
- •Teeth with mature roots
- •Signs and symptoms of irreversible pulpitis
- •Non-restorable teeth
- •Negative response to cold testing, the presence of sinus tract or swelling
- •No pulp exposure
- •Bleeding could not be controlled after full pulpotomy in 6 minutes
研究组 & 干预措施
Mineral trioxide aggegate
white mineral trioxide aggregate (MTA) calcium silicate-based cement
干预措施: mineral trioxide aggregate (Biological)
Mineral trioxide aggegate
white mineral trioxide aggregate (MTA) calcium silicate-based cement
干预措施: cervical pulpotomy (Procedure)
Mineral trioxide aggegate
white mineral trioxide aggregate (MTA) calcium silicate-based cement
干预措施: Local Anesthetics Procaine (Drug)
Biodentine
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
干预措施: Biodentine (Biological)
Biodentine
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
干预措施: cervical pulpotomy (Procedure)
Biodentine
calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
干预措施: Local Anesthetics Procaine (Drug)
结局指标
主要结局
presence of pain,sensitivity to percussion/ palpation
时间窗: 18 months
by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
presence of mobility
时间窗: 18 months
by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
Swelling or sinus tract
时间窗: 18 months
by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
次要结局
- Stage of root development(18 months)
- Presence of radiolucency(18 months)
研究者
Gihan M Abuelniel ,PhD
Associate Professor of Pediatric Dentistry
Cairo University