The Effect of Nano-Bio Fusion Gingival Gel Versus Natural Healing on the Palatal Wound Healing After Harvesting Free Gingival Graft.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
The main aim of soft tissue grafts is to treat mucogingival defects such as exposed root surfaces or augment gingival tissue dimensions. In single or multiple root coverage procedures, autogenous grafts are considered to be the gold standard. where the palate is considered to be the most frequent site for graft harvesting, this procedure is accompanied with complications such as postoperative pain and bleeding. Despite all materials used in the literature, no proven golden standard exits. This study will compare the effect of Nano-Bio Fusion gingival gel versus natural healing with stent as a palatal dressing in the management of wound healing and pain.
详细描述
In the literature, there are many modalities proposed in an attempt to decrease such complications such as the use of PRF, non-eugenol dressing Coe-pack, medicinal plant extract, hyaluronic acid. Despite all, no proven gold standard exits.
Nano- Bio Fusion gel is a highly functional paste containing (nano vitamin C, nano vitamin E and propolis extract) that was used before as an adjunct to scaling and root planning in the management of chronic periodontitis.
Owing to its natural composition, Vitamin C enhances the synthesis, maturation, secretion and degradation of collagen. Also, propolis extract is mainly composed of flavonoids possessing antimicrobial, anti-inflammatory and now recognized as owning regenerative capacities.
Whereas vitamin E acts as an antioxidant, free radical scavenger, facilitate angiogenesis and epithelialization. Thus, Nano Bio Fusion gel could be tested as a palatal wound dressing aiming to enhance postoperative wound healing and wound re-epithelization.
Palatal Stent will be used in the control group which was previously used in several studies. The choice of the stent was to confirm that any observed effect will be due to the gel only as stent will be used in both groups. Follow up will be over month.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy/controlled patients scheduled for various periodontal or peri-implant plastic surgeries, requiring palatal free gingival graft harvesting, either epithelialized or de-epithelialized.
- •Compliant Patients
- •Good Oral Hygiene
排除标准
- •Uncontrolled systemic diseases
- •Pregnancy or lactating females
- •Patients with severe gagging reflex
- •Patients unwilling to sign an informed consent
研究组 & 干预措施
Nano-biofusion gel gingival gel (NBF)
Coverage of the free gingival graft area in the palate with stent
干预措施: Nano-bio fusion gingival gel (Drug)
stent
Coverage of the free gingival graft area in the palate
干预措施: stent (Device)
结局指标
主要结局
Wound healing
时间窗: Change in healing from baseline up to 4 weeks
Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing)
次要结局
- Post-operative Pain Assessment(7 days)
- Patient Satisfaction(Day 30)
研究者
Sara Mohamed Mahmoud Abdelrehim
Principal Investigator
Cairo University