Exploring Natural Alternatives: Pomegranate Peel Extract for Primary Molar Pulpotomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- absence of pain
研究概览
简要总结
Pomegranate peel extract has demonstrated a range of potential uses in the biomedical industry in recent years because of its numerous benefits, which include anti-inflammatory, antibacterial, anti-apoptotic, antioxidant, and cell-regeneration-promoting qualities. Therefore, the purpose of this study will be to evaluate the clinical and radiographic efficacy of Pomegranate peel extract as a pulpotomy agent in primary teeth.
详细描述
A total of sixty primary molars in thirty children aged between 4 and 8 years will be randomly divided into two groups: Group I, the Pomegranate peel extract group, and Group II, the MTA group. After pulpotomy treatment, all molars will be restored with stainless steel crowns. Follow-up will be done after 3, 6, and 9 months for clinical and radiographic assessment.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Restorable primary molars with deep carious lesions.
- •Absence of gingival swelling or sinus tract.
- •Absence of spontaneous pain
- •Absence of pain on percussion.
- •Absence of discontinuity of lamina dura
- •Absence of internal root resorption.
- •Absence of external root resorption.
- •Absence of inter-radicular or periapical bone destruction (radiolucency).
排除标准
- •presence of spontaneous pain
- •presence of gingival swelling or sinus tract
- •presence of internal or external root resorption
- •pain on percussion.
结局指标
主要结局
absence of pain
时间窗: up to 9 months
Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain
furcation radiolucency
时间窗: 9 months
Description: Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)
absence of fistula
时间窗: up to 9 months]
Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling
Tenderness to percussion
时间窗: up to 9 months
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
Furcation radiolucency
时间窗: 3 months
Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value)
次要结局
未报告次要终点
研究者
Shaimaa Shaban Mohamed El-desouky
associate professor of pediatric dentistry, faculty of dentistry, Tanta university
Tanta University