Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Epithelialization
研究概览
简要总结
The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.
详细描述
Free gingival graft obtained in the palatal region causes morbidity. Therefore, clinicians try to overcome these difficulties by isolating the wound in the palatal region from the oral environment and/or accelerating wound healing.
Periodontal dressings, acrylic stents, hemostatic agents, surgical sponges, platelet concentrates, low-level laser therapy, photobiomodulation, cyanoacrylate tissue adhesives and hyaluronic acid are some of the methods used for donor site management or to accelerate healing.
Cyanoacrylate adhesives form an adhesive film through rapid polymerization triggered by the hydroxyl groups on the surfaces to which they are applied. They have both bacteriostatic and hemostatic properties.
In recent years, it has been observed that the use of platelet concentrates such as Platelet Rich Plasma (PRP), Platelet Rich Fibrin (PRF) and autogenous products such as CGF (concentrated growth factor) in periodontal treatments has increased.
CGF is obtained by centrifuging blood in four different cycles and times. This product contains a relatively intact fibrin clot containing platelets, leukocytes, various growth factors and cytokines. CGF can be applied as a carrier of growth factors and/or a barrier membrane to aid tissue regeneration and wound healing in clinical applications.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy
- •not had periodontal surgery in the last 6 months
排除标准
- •allergic to medication
- •high anxiety (using modified dental anxiety scale)
研究组 & 干预措施
Group 1 (Control group)
After FGG is taken from the palatal area, the sponge is placed in the wound area.
干预措施: Free gingival graft procedure (Procedure)
Group 2 (Cyanoacrylate group)
After the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area.
干预措施: Free gingival graft procedure (Procedure)
Group 3 (Concentrated Growth Factor group)
After the FGG is taken from the palatal area, concentrated growth factor (CGF) group is placed in the wound area. CGF is obtained by centrifuging blood in four different cycles and times.
干预措施: Free gingival graft procedure (Procedure)
结局指标
主要结局
Epithelialization
时间窗: The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized.
VAS
时间窗: The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.
The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain)
次要结局
- Number of analgesic drugs(Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.)
- Color Match(The color match is evaluated on the 7th, 14th, 21st and 28th days.)
- Healing Index(The Healing Index is recorded on the 7th day.)
- Secondary Bleeding(Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.)
研究者
Dicle Altındal
DDS, Assistant Professor
Yuzuncu Yil University