Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Radiographic linear defect depth
研究概览
简要总结
Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?
详细描述
Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019).
Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.
- •Non-smokers
- •No pregnancy
- •Medically free
- •Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm;
- •Presence of ≥2 mm of keratinized gingiva at the tooth with the defect.
- •Willingness to optimal compliance with the study procedures
排除标准
- •Uncontrolled systemic or local infection in the tissue of interest,
- •History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).
- •History of chronic autoimmune disease
- •Participation in an intervention trial in the same quadrant in the previous two months.
- •Type III tooth mobility, vertical root fracture in the selected tooth.
- •Contraindications for periodontal surgery.
研究组 & 干预措施
Group 1 Control
PRF in intra-bony defects
干预措施: Platelet Rich Fibrin (PRF) (Biological)
Group 2 Experimental
PRF and Retinol in intra-bony defects
干预措施: Platelet Rich Fibrin (PRF) and Retinol (Biological)
结局指标
主要结局
Radiographic linear defect depth
时间窗: 6 Month
Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004)
次要结局
- Radiographic defect bone density(6 MOnth)
- Probing pocket depth(6 Month)
- Clinical attachment level(6 Month)
研究者
Abdallah Hassan Mostafa
B.Sc., M.Sc. Abdallah Hassan Mostafa
Cairo University