Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Absence of clinical signs of pulp degeneration.
研究概览
简要总结
The aim of this study was to assess clinically, radiographically, and histologically the regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to Biodentine™ (BD) in pulpotomized primary teeth.
详细描述
The study was a parallel design, randomized controlled clinical trial It was conducted in the out-patient clinic of the Pediatric Dentistry and Dental public health department after obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical considerations after showing significant clinical failure in the TAMP-BG group and after performing interim analysis.
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
The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children free of any systemic disease or special health care needs.
- •Children not receiving any anti-inflammatory medication.
- •Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
- •Restorable teeth.
- •Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber and not requiring more than 5 minutes to achieve hemostasis after coronal pulp amputation.
- •Teeth indicated for extraction for orthodontic purposes with the previously mentioned criteria (required for a subgroup for assessment of histological and inflammatory response outcomes).
排除标准
- •Teeth with clinical or radiographic signs of pulp degeneration.
研究组 & 干预措施
TAMP bioglass
Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.
干预措施: TAMP bioglass (Drug)
Biodentine ™
Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.
干预措施: Biodentine (Drug)
结局指标
主要结局
Absence of clinical signs of pulp degeneration.
时间窗: 1 month postoperatively
Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
Percentage of Teeth with no clinical signs of pulp degeneration.
时间窗: 12 months postoperatively
Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
Percentage of Teeth with no radiographic signs of pulp degeneration.
时间窗: 12 months postoperatively
Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening
次要结局
- Inflammatory response using light microscopy(6 weeks)
- Percentage of teeth with radiographic evidence of dentin bridge formation(12 months postoperatively)
- Dentin bridge formation using light microscopy(6 weeks)
- The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.(6 weeks)
研究者
Nourhan M.Aly
Clinical Instructor
University of Alexandria