Survival Rate of Lesion Sterilization and Tissue Repair Using Triple Antibiotic and Double Antibiotic Paste in Primary Molars: A Triple-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Clinical Criteria:
研究概览
简要总结
not applicable
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Advanced root resorption more than two-thirds.
- •Severe bone loss in the furcal and periapical area due to pulpitis.
- •Pathologic mobility due to periapical infection from pulpities.
- •Radiolucency in the furcal area.
- •Patients not willing for extraction.
- •Presence of abscess Presence of sinus.
排除标准
- •Children with systemic disease.
- •Children with allergies to antibiotics.
- •Developmentally and medically compromised children.
- •Teeth with perforated floor.
- •Excessive bone loss in the furcation area extending to the crypt of underlying tooth bud.
- •Non-restorable crown.
结局指标
主要结局
Clinical Criteria:
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
Immediate post-operative absence of spontaneous pain
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
No tenderness to percussion
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
No mobility
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
No intraoral or extraoral swelling
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
No sinus tract
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
Radiographic Criteria:
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
Internal root resorption
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
External root resorption
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
Bone resorption / Peri-radicular radiolucency
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
Cyst formation
时间窗: Resolution of clinical signs and symptoms will be evaluated using the index within one month after treatment. At each subsequent visit, clinical and radiographic evaluations will be conducted every 6 months for a period of 2 years.
次要结局
- Survival Rate Evaluation:(Categorization of success and failure will be defined and calculated using the validated composite index.)
研究者
Dr Shaniya Sain
Department of Pediatric and Preventive Dentistry,PMS College of Dental Science and Research