Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Clinical success of pulpotomy
研究概览
简要总结
This study aimed to evaluate the clinical and radiographic outcomes of photobiomodulation pulpotomy compared to MTA pulpotomy in primary molars in children.
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
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
- •Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
- •Lack of history of allergy to the materials used for anesthesia and sulfite.
- •Children free of any systemic disease or special health care needs (ASA 1).
- •Completion of the written informed consent form by parents/guardian.
排除标准
- •Children who receive any analgesic drugs at least 24 hours before treatment.
- •Any inflammation or lesion in the injection site
- •Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
- •Child coming for emergency treatment of pain.
- •If hemostasis is not achieved within five minutes after application of moist cotton pellet directly to the pulp stumps
- •If radicular pulp tissue was not vital due to the presence of suppuration or purulent necrosis (pus discharge).
研究组 & 干预措施
Photobiomodulation
干预措施: Photobiomodulation (Device)
Mineral Trioxide Aggregate (MTA)
干预措施: MTA (Drug)
结局指标
主要结局
Clinical success of pulpotomy
时间窗: up to 12 months
Patients will be assessed and the presence of any adverse clinical signs or symptoms pain, or swelling will be considered clinical criteria of failure
Radiographic success of pulpotomy
时间窗: up to 12 months
Periapical x-ray will be performed and the presence of any any periapical radiolucency, furcation involvement, widening of periodontal ligament space (PDL), and pathologic internal/external root resorption will be considered radiographic failure.
Tissue healing
时间窗: 24 hours
Tissue healing after stainless steel crown (SSC) insertion will be assessed according to gingival index scale to determine the gingival condition around the inserted SSC. The adopted Löe and Silness gingival index scale ranges from 0 to 3 for the buccal, lingual, mesial and distal surfaces, and will be scored as follows: 0 indicates no inflammation and healthy gums; 1 indicates mild inflammation where there is slight color changes, slight edema and no bleeding on probing; 2 indicates moderate inflammation where there is edema with slight redness and bleeding upon probing; and 3 indicates severe inflammation where there is severe edema, redness, presence of ulceration and a tendency for spontaneous bleeding.
次要结局
未报告次要终点
研究者
Aliaa Hamouda
Assistant Lecturer of Pediatric Dentistry
Alexandria University