Evaluating the Clinical and Radiographic success rate of Herbal Products Used with Zinc Oxide and Endoflas as an Obturating Material in Primary mandibular molars among 4-8 years children : A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- All cause morbidity at 6 months. Success rate of
研究概览
简要总结
A randomized controlled trial was conducted to evaluate the clinical and radiographic success rate of herbal products used with zinc oxide and Endoflas as obturating materials in primary mandibular molars of children aged 4 to 8 years. The study included 45 children divided into three groups: Group 1 (zinc oxide with neem extract), Group 2 (zinc oxide with aloe vera extract), and Group 3 (Endoflas), with 15 children in each group.
The inclusion criteria were primary mandibular molars with deep carious lesions requiring pulpectomy. For the neem group, mature neem leaves were collected, washed, and macerated with 70 percent ethanol. The extract was filtered, the alcohol removed via water bath, and the extract stored in an airtight container. Zinc oxide powder was mixed with neem extract in a 1 gram to 0.4 milliliter ratio to form a paste.
For the aloe vera group, fully extended aloe leaves were washed to remove aloine, disinfected with isopropyl alcohol, peeled, and the pulp collected. This pulp was mixed with zinc oxide powder in a 1 to 2 ratio.
For the Endoflas group, a homogenous mix was prepared. A thin layer was applied to root canal walls using reamers, followed by a thick mix inserted with a hand plugger or cotton pellet. Outcome assessment using Clinical and Radiographic Outcomes at 6-Month Follow-Up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with age group between 4 and 8 years.
- •Primary mandibular molars with the presence of deep carious lesions which are indicated for pulpectomy Radiographic evidence of deep carious lesion or lesion with radiographic pulp exposure At least 2/3rd of root length present and having adequate bony coverage, presence, or absence of intra-radicular or periradicular radiolucency not involving permanent tooth bud.
排除标准
- •Medically compromised children Presence of pathologic or physiologic mobility.
- •Non-restorable primary molars and radiographically obliteration of root canal Presence of internal and external resorption.
结局指标
主要结局
All cause morbidity at 6 months. Success rate of
时间窗: Baseline, 1 month, 3 months, 6 months
pulpectomy at 6 months (defined as absence of
时间窗: Baseline, 1 month, 3 months, 6 months
clinical symptoms and radiographic signs of
时间窗: Baseline, 1 month, 3 months, 6 months
pathology).
时间窗: Baseline, 1 month, 3 months, 6 months
次要结局
- All cause morbidity at 1, 3 months, 6 months. Incidence of post-operative pain, patient satisfaction using Likert scale.(Baseline, 1 month, 3 months, 6 months)
研究者
PREETHI R
Adhiparasakthi Dental College and Hospital