Evaluation of the Success of TheraCal PT and Biodentine in Pulpotomy Treatment of Primary Teeth and the Effect of Low-Level Laser Therapy (LLLT) on Treatment Outcomes
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NECIBE DAMLA ŞAHIN
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars
概览
简要总结
This randomized clinical study aimed to compare the clinical and radiographic outcomes of TheraCal PT and Biodentine in pulpotomy treatment of primary teeth and to evaluate the influence of low-level laser therapy (LLLT) on treatment outcomes in pediatric patients.
详细描述
This prospective randomized clinical trial was conducted at Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry. The study included healthy children aged 4 to 9 years who required pulpotomy treatment for primary molar teeth.
Eligible teeth were randomly allocated into four groups according to the pulpotomy material used and the application of low-level laser therapy (LLLT): (1) Biodentine, (2) LLLT + Biodentine, (3) TheraCal PT, and (4) LLLT + TheraCal PT.
Low-level laser therapy was performed using a 940 nm diode laser in non-contact mode immediately after coronal pulp removal. All treated teeth were restored with stainless steel crowns. Clinical and radiographic evaluations were scheduled at baseline and at 3, 6, and 12 months follow-up visits.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor was blinded to the treatment groups during clinical and radiographic evaluations. Participants and operators were not blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged between 6 and 9 years. Primary molars with carious exposures requiring pulpotomy treatment. Teeth with vital pulp confirmed by the absence of spontaneous pain and the presence of normal bleeding after coronal pulp removal.
- •Teeth with restorable crowns suitable for stainless steel crown restoration. Cooperative patients who can attend all follow-up appointments.
排除标准
- •Teeth with signs of irreversible pulpitis or necrosis (e.g., spontaneous or nocturnal pain).
- •Teeth with internal or external root resorption, furcal or periapical radiolucency.
- •Non-restorable teeth or those with excessive loss of crown structure. Patients with systemic diseases or on long-term medication that could affect healing.
- •Uncooperative children or those lost to follow-up.
结局指标
主要结局
Clinical and Radiographic Success Rate of Pulpotomy Treatments in Primary Molars
时间窗: 12 months after treatment
Number of teeth with clinical success defined as absence of spontaneous pain, swelling, sinus tract, pathological mobility, or tenderness to percussion, and number of teeth with radiographic success defined as absence of internal or external root resorption and absence of furcal or periapical radiolucency. Results will be reported as number and percentage of successful teeth.
次要结局
- Interim Clinical and Radiographic Success Rates(3 and 6 months after treatment)
- Effect of Low-Level Laser Therapy (LLLT) on Pulpotomy Success(12 months after treatment)
研究者
NECIBE DAMLA ŞAHIN
Assistant Professor
Tokat Gaziosmanpasa University