Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical findings
研究概览
简要总结
The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.
详细描述
The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
- •Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
- •Presence of a small carious or traumatic pulp exposure (1 mm or less).
- •Radiographic:
- •Presence of at least two-thirds of root length.
- •Normal lamina dura and periodontal ligament space.
排除标准
- •History of spontaneous unprovoked toothache.
- •Extensive crown destruction that preclude coronal restoration.
- •Gingival swelling, sinus tract or other soft tissue pathology.
- •Abnormal tooth mobility.
- •A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
- •No evidence of visible pulp exposure.
- •Radiographic:
- •Furcation/periapical radiolucency.
- •Pathological internal/external root resorption.
- •Absence of underlying permanent successor
研究组 & 干预措施
Group I (control): Calcium hydroxide cement
Pulp capping material
干预措施: direct pulp capping in primary molars (Other)
Group 2: Premixed bioceramic putty
Pulp capping material
干预措施: direct pulp capping in primary molars (Other)
结局指标
主要结局
Clinical findings
时间窗: 2 year follow up
The children will be recalled for postoperative clinical \& radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four months.the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. Pain. 2. Tenderness to palpation or percussion 3. Gingival swelling or sinus tract. 4. Purulent exudate expressed from the gingival margin. 5. Abnormal tooth mobility.
次要结局
未报告次要终点
研究者
Merrette Basem Khalaf Sedhom
Resident in Pediatric and Community Dentistry Department, Faculty of Dentistry, Assuit University
Assiut University