Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Clinical and radiographic success at 6 months
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients.
The main questions it aims to answer are:
- Is LSTR antibiotic paste (CTZ paste) effective in treating primary molars with pulp necrosis?
- Is ZOE pulpectomy effective in treating primary molars with pulp necrosis, and how does its efficacy compare with LSTR therapy?
Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months.
Participants will:
- Be randomly assigned to one of the two treatment groups after diagnosis of pulp necrosis in primary molars.
- Receive treatment under standard behavior management techniques with local anesthesia following topical application of 2% lignocaine gel and rubber dam isolation.
- Undergo either Lesion Sterilization and Tissue Repair (LSTR) therapy with CTZ paste or zinc oxide eugenol (ZOE) pulpectomy according to group allocation.
- Return for a clinical and radiographic follow-up evaluation after six months to assess treatment outcomes.
- Allow researchers to record their clinical findings and radiographic results to evaluate the efficacy of both treatment methods.
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 (Participant)
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 of both genders
- •4 years and 10 years
- •Pulp necrosis in mandibular primary molars with minimum of 2/3 of the roots
- •Consent from Parents/Guardian of children.
- •Sufficient crown structure for restoration
排除标准
- •• Children who have a physical or mental change.
- •Involving systemic illnesses.
- •History of allergy to drugs being utilized
- •Antibiotics use within three months
- •Teeth with aberrant root resorption or pulp canal obliteration on periapical radiography
研究组 & 干预措施
LSTR therapy
Participants in this group receive CTZ antibiotic paste placed in the pulp chamber after irrigation.
干预措施: Group A - LSTR Therapy (CTZ Paste) (Drug)
Zinc Oxide Eugenol (ZOE) Pulpectomy
Participants in this group receive conventional pulpectomy with ZOE paste placed in the root canals.
干预措施: Group B - ZOE Pulpectomy (Procedure)
结局指标
主要结局
Clinical and radiographic success at 6 months
时间窗: 6 months
Clinical success: Absence of sinus tract, soft tissue swelling, or edema. Radiographic success: Reduction or complete disappearance of the initial periapical radiolucency and no appearance of new radiolucency.
次要结局
未报告次要终点
研究者
Hira Zaman
Assistant Professor
University of Faisalabad