EVALUATION OF THE CLINICAL AND RADIOGRAPHIC SUCCESS OF VARIOUS MODIFICATIONS OF THE LESION STERILIZATION AND TISSUE REPAIR TECHNIQUE IN PRIMARY SECOND MOLAR TEETH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical Success of LSTR Treatment
研究概览
简要总结
This study aimed to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars. The study included systemically healthy children aged 4-11 years. Participants were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and vehicle used [Macrogol-Propylene Glycol (MP) or normal saline (NS)]: 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS. Clinical outcomes were evaluated at 3, 6, and 12 months after treatment, and radiographic outcomes were evaluated at 6 and 12 months. The clinical and radiographic success of the four LSTR modifications was compared over the 12-month follow-up period.
详细描述
This study was conducted to evaluate and compare the clinical and radiographic success of different antibiotic and vehicle modifications of the Lesion Sterilization and Tissue Repair (LSTR) technique in infected mandibular primary second molars.
A total of 64 systemically healthy children aged 4-11 years were included in the study. The cases were assigned to four treatment groups according to the antibiotic combination (3Mix or 2Mix) and the vehicle used [Macrogol-Propylene Glycol (MP) or Normal saline (NS)]. The four treatment groups were 3Mix-MP, 3Mix-NS, 2Mix-MP, and 2Mix-NS.
Following LSTR treatment, clinical evaluations were performed at 3, 6, and 12 months, while radiographic evaluations were performed at 6 and 12 months. Clinical and radiographic findings were assessed at the specified follow-up periods to determine treatment success and to compare the outcomes of the four LSTR modifications over a 12-month follow-up period.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-11 years. Systemically healthy children. Presence of deep caries, pulp necrosis, or irreversible pulpitis in a mandibular primary second molar indicated for LSTR treatment.
- •Patients unsuitable for conventional pulpectomy due to poor cooperation. At least 6 months remaining before physiological exfoliation of the affected tooth.
- •Root resorption not exceeding one-third of the root length. No furcation perforation. Furcation radiolucency not extending to the permanent tooth germ. Sufficient remaining tooth structure for restoration. Parent/legal guardian willing to provide informed consent.
排除标准
- •Risk of infective endocarditis. Known allergy to any antibiotic used in the study. Root resorption exceeding one-third of the root length. Extensive furcation involvement extending toward the permanent tooth germ. Insufficient remaining tooth structure for restoration. Parent/legal guardian declining informed consent.
研究组 & 干预措施
2Mix-NS
Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with normal saline (NS) as the vehicle.
干预措施: 2Mix-NS Antibiotic Paste (Drug)
2Mix-MP
Participants in this arm received LSTR treatment using the 2Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
干预措施: 2Mix-MP Antibiotic Paste (Drug)
3Mix-MP
Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with Macrogol-Propylene Glycol (MP) as the vehicle.
干预措施: 3Mix-MP Antibiotic Paste (Drug)
3Mix-NS
Participants in this arm received LSTR treatment using the 3Mix antibiotic combination with normal saline (NS) as the vehicle.
干预措施: 3Mix-NS Antibiotic Paste (Drug)
结局指标
主要结局
Clinical Success of LSTR Treatment
时间窗: 3, 6, and 12 months after treatment
Clinical success was defined as the absence of pain or tenderness, swelling or fistula, pathological mobility, and tenderness to percussion. The presence of any of these signs or symptoms was considered clinical failure
Radiographic Success of LSTR Treatment
时间窗: 6 and 12 months after treatment
Radiographic success was defined as stabilization, reduction, or complete resolution of existing interradicular and periradicular radiolucency, with no development of new radiographic lesions. Failure to meet any of these criteria was considered radiographic failure.
Overall Success of LSTR Treatment
时间窗: 6 and 12 months after treatment
Overall treatment success was defined as fulfillment of both the clinical and radiographic success criteria. A case was considered unsuccessful if either the clinical or radiographic success criteria were not met.
次要结局
未报告次要终点