Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis.
A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi. Participants will be randomly assigned to one of two groups:
Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime).
Group 2 (Intervention): LSTR using Simvastatin paste.
Both materials will be placed after non-instrumentation cleaning and sealed with glass ionomer cement, followed by stainless steel crown placement. Patients will be evaluated clinically and radiographically at 1, 2, and 3 months post-treatment.
Primary outcomes include clinical success (absence of pain, swelling, or sinus tract) and radiographic success (reduction or absence of periapical radiolucency). Data will be analyzed using SPSS v26, with chi-square and t-tests applied as appropriate; p < 0.05 will be considered significant.
This study seeks to determine whether Simvastatin, owing to its antibacterial, anti-inflammatory, and regenerative properties, can serve as a viable alternative to antibiotic-based LSTR in managing necrotic primary teeth.
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young, healthy patient, ranging in age from 5-8 years.
- •Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
- •Having maxillary and mandibular primary molars with:
- •Spontaneous pain or tenderness to percussion.
- •Deep cavity extending to the pulp chamber.
- •Chronic Abscess or draining sinus.
- •Restorable.
- •To be kept for less than a year.
- •Irregular mobility that is not related to exfoliation.
排除标准
- •Uncooperative patients.
- •Children with a history of allergic reaction with antibiotics.
- •Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.
研究组 & 干预措施
Simvastatin
Lesion Sterilization and Tissue Repair using Simvastatin.
干预措施: Lesion Sterilization and Tissue Repair using Simvastatin. (Combination Product)
Triple Antibiotic Paste
Lesion Sterilization and Tissue Repair using triple antibiotic paste
干预措施: Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste. (Combination Product)
结局指标
主要结局
Clinical Success
时间窗: 1 month, 2 month and 3 month.
Change in pain through visual analog scale and size of swelling in millimeters will be assessed to measure clinical success.
Radiographic success
时间窗: 1 month, 2 month and 3 month
Change in radiolucency through the periapical index will be measured to assess radiographic success.
次要结局
未报告次要终点
研究者
Waleed Mumtaz
Postgraduate Trainee- FCPS
Dow University of Health Sciences