Clinical Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound After Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Post Operative Pain
研究概览
简要总结
To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.
详细描述
To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction , Color match , Wound size closure after free gingival graft harvesting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mucogingival defects scheduled for free gingival graft
- •Systemically healthy
排除标准
- •Occlusal trauma at site of graft
- •Pregnancy and lactation
- •Patients allergic to the used agents
- •Severe gagging reflex
研究组 & 干预措施
Ozone Gel
Ozone is a potent oxidant with marked antimicrobial activity and the potential to act as a metabolic and host immune modulator.The routes of ozone administration are topical and regional for both gaseous and aqueous forms .Ozone gel is contains ozonated extra virgin olive oil and Arnica montana extract, containing essential fatty acids Ozone gel was claimed to have analgesic (Tasxdemir et al,2016) and anti-inflammatory effect its high content of essential fatty acids and the effect of ozone, natural extra virgin olive oil (I. Lezcano,et al.2000). Ozone gel has a beneficial role in wound healing, Its wound healing properties may be due to enhancing blood circulation and immune response.(M.colombo et,al 2019), Generic name : GeliO3 Dosage form : Gel Frequency/Duration : Once on this interval : 0,3,7,14
干预措施: GeliO3 (Drug)
Hyaluronic Acid 0.2%
HA was Known for hygroscopicity that allows it to maintain conformational stiffness and to retain water.(Yıldırım et al., 2017b) .Another major feature is viscoelasticity that provides stability and elasticity to tissues and delays penetration of viruses and bacteria (Finn, Schow and Schneiderman, 1992) .
In periodontology, HA has been advocated as monotherapy(Hammad et al., 2011) or as an adjunct to non-surgical and/or surgical (Fawzy El-Sayed et al., 2012) periodontal treatment to reduce inflammation and promote wound healing.
HA gel was used in two different concentrations 0.2% and 0.8% versus negative control in the management of post-operative pain after FGG surgery and it was found effective with more superior results for the 0.2% concentration (Yıldırım et al., 2017b).
Generic name : GingiGel Dosage form : Gel Frequency/Duration : Once on this interval : 0,3,7,14
干预措施: Gingi gel (Drug)
结局指标
主要结局
Post Operative Pain
时间窗: 14 days
Post operative pain measured directly through VAS score with 0 means no pain and 10 means the maximum pain or indirectly by analgesics consumption by the patient
次要结局
- Wound Size(42 days)
- Color Match(42 days)
研究者
Hisham Tarek Mahmoud Ahmed
The Principal Investigator
Cairo University