Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Clinical success after pulpotomy
研究概览
简要总结
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.
详细描述
Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, >50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups:
Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries.
Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry.
Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted.
The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.
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
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients with deep dental decay in primary molars
- •Teeth with signs and symptoms of reversible pulpitis
排除标准
- •Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
- •Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
- •Teeth that are not restorable
研究组 & 干预措施
Indirect pulp cap
IDP will be performed for this group
干预措施: Vitrebond (Device)
MTA pulpotomy
MTA pulpotomy will be performed for this group
干预措施: Mineral Trioxide Aggregate (Drug)
Biodentin pulpotomy
Biodentin pulpotomy will be performed for this group
干预措施: Biodentin (Drug)
结局指标
主要结局
Clinical success after pulpotomy
时间窗: 3 years
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Clinical success after indirect pulp cap
时间窗: 3 years
No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post-operative pain, no pain on palpation or percussion of the tooth
Radiographic success after pulpotomy
时间窗: 3 years
No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space
次要结局
未报告次要终点
研究者
Vineet Dhar
Associate Professor, Graduate Program Director
University of Maryland, Baltimore