Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Tenderness to percussion
研究概览
简要总结
The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.
详细描述
The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.
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)
盲法说明
Double
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children:
- •Cooperative children aged 4 -7 years old.
- •Systemically healthy.
- •Clinical criteria:
- •Necrotic primary mandibular second molar teeth.
- •Spontaneous pain or tenderness to percussion
- •Deep carious lesion with pulp exposure.
- •Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)
- •Radiographic criteria:
- •Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
- •Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)
排除标准
- •Children:
- •With physical or emotional alteration.
- •Children with systemic disease.
- •Previous history of allergy to antibiotics used in the study.
- •Children that will not attend follow up. • Teeth:
- •Non restorable carious primary molars.
- •Grade III mobility
研究组 & 干预措施
Zinc-oxide Propolis (Zno-P)
Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal.
干预措施: Zinc oxide propolis (Combination Product)
Modified triple antibiotic paste
Metronidazole tablets 500 mg (Flagyl®, Sanofi, Egypt), ciprofloxacin tablets 500 mg (Ciprofloxacin tablets USP 39®, European pharmaceuticals, Egypt,), and clindamycin capsules 300 mg(Dalacin C™ Pfizer, Egypt) will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal.
干预措施: Modified triple antibiotic paste (Combination Product)
结局指标
主要结局
Tenderness to percussion
时间窗: 1 year
(binary outcome measured by percussion test using back of the dental mirror
Postoperative pain
时间窗: 1 year
Binary outcome measured with direct questioning to the patient
Swelling / sinus tract
时间窗: 1 year
binary outcome measured with visual examination of the patient examination of the patient
Mobility
时间窗: 1 year
(measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success
次要结局
- Radiographic success(6 months)
研究者
Sara Khaled Adam
Assistant lecturer pediatric dentistry
Cairo University