Comparison of Lesion Sterilization and Tissue Repair Technique With Conventional Pulpectomy in the Treatment of Pulpal Lesions in Primary Molars in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Clinical Success Rate of Treated Primary Molars
研究概览
简要总结
This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. LSTR is a minimally invasive method that uses antibiotic paste to disinfect infected tissue without full canal instrumentation. Children participating in this study will receive either the LSTR technique or standard pulpectomy, and the clinical and radiographic success of both treatments will be evaluated over a 12-month period. The goal is to determine whether LSTR is a safe and effective alternative to pulpectomy in primary teeth.
详细描述
This is a prospective, comparative clinical trial conducted at Atatürk University, Department of Pediatric Dentistry, Erzurum, Turkey. The study compares two endodontic treatment methods for primary molars with pulpal lesions in children aged 4 to 10 years. A total of 110 primary molar teeth from 98 pediatric patients were included. Teeth were assigned to two main treatment groups: the experimental group receiving Lesion Sterilization and Tissue Repair (LSTR) and the control group receiving conventional pulpectomy. Each group was further divided into two subgroups based on the type of final restoration - stainless steel crown (SSC) or compomer - resulting in four treatment-restoration combinations: LSTR + SSC, LSTR + compomer, pulpectomy + SSC, and pulpectomy + compomer. Restoration type was determined based on patient cooperation and parental preference.
The LSTR group was treated with a combination of ciprofloxacin and metronidazole antibiotics mixed with iodoform-calcium hydroxide paste (Viopex), applied to the canal orifices without mechanical instrumentation. The pulpectomy group received standard chemomechanical canal debridement and obturation with iodoform-calcium hydroxide paste. Both groups were subsequently restored with either SSC or compomer.
Patients were followed up clinically and radiographically at 3, 6, and 12 months. Clinical parameters assessed included spontaneous pain, percussion sensitivity, abscess, fistula, and pathological mobility. Radiographic parameters included periapical and interradicular lesion resolution, internal root resorption, and external root resorption. Overall tooth survival was evaluated using Kaplan-Meier survival analysis and Log-Rank test. The primary objective was to assess whether LSTR achieves similar clinical and radiographic success compared to conventional pulpectomy, and to determine the effect of restoration type on long-term treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 10 years.
- •Presence of at least one primary molar with pulpal involvement requiring endodontic treatment.
- •Good general health without systemic conditions.
- •Signed informed consent from parent or legal guardian.
排除标准
- •Children with systemic diseases or immune-compromising conditions.
- •Known allergies to any of the materials or antibiotics used in the study.
- •Uncooperative behavior preventing dental treatment under normal clinical conditions.
- •Teeth with non-restorable crown structure or excessive root resorption.
研究组 & 干预措施
LSTR Group
Children will receive the LSTR (Lesion Sterilization and Tissue Repair) procedure, which includes applying a mixture of ciprofloxacin and metronidazole with iodoform-calcium hydroxide paste to the pulp chamber without canal instrumentation. Restoration will be done using a stainless steel crown or compomer.
干预措施: LSTR (Procedure)
Pulpectomy Group
Children will receive conventional pulpectomy involving mechanical canal instrumentation and obturation with iodoform-calcium hydroxide paste. Restoration will be completed with a stainless steel crown or compomer based on clinical conditions.
干预措施: Pulpectomy (Procedure)
结局指标
主要结局
Clinical Success Rate of Treated Primary Molars
时间窗: At 3, 6, and 12 months post-treatment
Clinical success is defined as absence of pain, swelling, sinus tract, and pathological mobility assessed through standardized clinical examination by a pediatric dentist.
次要结局
- Radiographic Healing Rate of Treated Primary Molars(At 6 and 12 months post-treatment)
研究者
taymour abuawwad
PhD Candidate in Pediatric Dentistry
Ataturk University