Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of clinical success of photodynamic therapy
研究概览
简要总结
This study will be conducted to evaluate clinical and radiographic success of Photodynamic Therapy for root canal treatment of primary molars in comparison to the standard root canal treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-7 years.
- •Apparent healthy child not suffering from any mental or physical disability.
- •Cooperative children.
- •Restorable teeth.
- •Each child should have at least one carious primary molar with signs and symptoms of irreversible pulpitis or pulp necrosis.
- •Absence of internal and / or external perforation in the furcation area.
- •At least 2/3 thirds of the roots should be remained.
排除标准
- •Children with compromised health or physical disability.
- •Resorption of the roots more than 2/3 thirds.
- •Non restorable teeth.
结局指标
主要结局
Evaluation of clinical success of photodynamic therapy
时间窗: 14 months
The following criteria will be used for the determination of treatment success or failure: 1. Repair (= success) Clinically: absence of signs and symptoms. 2. Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis.
Evaluation of radiographic success of photodynamic therapy
时间窗: 14 months
The following criteria will be used for the determination of treatment success or failure: 1. Complete repair (= success) Radiographically: absence of pathological root resorption, normal width of periodontal ligament space, absence of lesion development in periapical regions in cases of absence of lesion in the initial diagnostic radiograph and complete regression of lesion in cases of presence of lesion in the initial diagnostic radiograph. 2. Incomplete repair (= success) Radiographically: absence of pathological root resorption and reduction lesion size in the periapical region. 3. Lack of repair (= failure) Radiographically: presence of pathological root resorption, lesion in furcation/periapical region unchanged in size during follow-up period, increase in lesion size or the development of a new lesion.
次要结局
未报告次要终点
研究者
Mohamed Elsayed Abo Farrag
assistant lecturer at paediatric dentistry department
Mansoura University