The Effect of Platelet-Rich Plasma on Wound Healing After Gingivectomy: A Randomized Clinical Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The amount of wound healing
研究概览
简要总结
The aim of the study is to evaluate the effects of using droplet-form platelet-rich plasma (PRP), known to have positive effects during the intermediate healing process, on wound healing in areas left for secondary healing after gingivectomy.
After the gingivectomy procedure, patients will be divided into four groups, each consisting of 10 individuals:
Group 1 (Control Group): This group will follow the standard post-gingivectomy protocol without any agent applied to the surgical site.
Group 2 (Placebo Group): In this group, the standard protocol will be followed, and physiological saline will be applied to the surgical site in 3-4 drops, four times a day, for 14 days.
Groups 3 and 4 (Study Groups): These groups will follow the standard protocol, with PRP prepared using different kits applied to the surgical site in 3-4 drops, four times a day, for 14 days.
All patients in the groups will be evaluated on the 3rd, 7th, 14th, and 30th days after the gingivectomy procedure. Postoperative pain will be assessed using the Visual Analog Scale (VAS), while wound healing will be evaluated using the Healing Index (Landry et al.) based on photographs of the region. Before taking standardized photographs, the surgical area will be stained with two-tone dye.
详细描述
The aim of this study is to evaluate the effectiveness of platelet-rich plasma (PRP) prepared with different kits in improving the healing rate and enhancing patient comfort during the recovery process in the secondary healing areas following gingivectomy.
Systemically healthy individuals, patients with inflammatory gingival overgrowth, patients without periodontal treatment in the operative area within the last year, non-smokers and patients with intact periodontal structures will be included to the study. Also pregnant or breastfeeding patients, Patients below 18 or above 55 ages, smoking patients, patients with systemic diseases and who received periodontal treatment in the operative area within the last year and who use of medications causing gingival overgrowth will be excluded from the study.
Methodology:
A total of 40 patients meeting the inclusion criteria and willing to participate in the study will be recruited from those attending the Periodontology Clinic at Erciyes University Faculty of Dentistry for gum disease treatment.
Initial Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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 individuals
- •Patients with inflammatory gingival overgrowth
- •Patients who have not received periodontal treatment in the area to be treated within the last year
- •Non-smokers
- •Patients with intact periodontal structures
排除标准
- •Pregnancy or lactation
- •Age under 18 or over 55
- •Presence of systemic diseases
- •Patients who have received periodontal treatment in the area to be treated within the last year
- •Use of medications causing gingival overgrowth
研究组 & 干预措施
Group 1 (Control group)
Standard post-gingivectomy protocol without any agent applied to the surgical site
Group 2 (Placebo)
Standard protocol with 3-4 drops of physiological saline applied to the surgical site, four times a day, for 14 days.
干预措施: Placebo (Other)
Group 4 (PRP Kit 2)
Standard protocol with PRP prepared using Kit 2, applied to the surgical site in the same manner as the placebo group.
干预措施: PRP (Other)
Group 3 (PRP Kit 1)
Standard protocol with PRP prepared using Kit 1, applied to the surgical site in the same manner as the placebo group.
干预措施: PRP (Other)
结局指标
主要结局
The amount of wound healing
时间窗: On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure
The wound area was stained with two-tone dye, and standardized photographs will be taken. Wound healing then was evaluated using the Healing Index (Landry et al.) based on the photographs. The Healing Index is designed on a 1-5 scale, where 1 indicates very poor healing, and 5 indicates excellent healing.
次要结局
- Periodontal changes(Before the initial periodontal treatment and at the first month after gingivectomy)
- postoperative pain(On the 3rd, 7th, 14th, and 30th days following the gingivectomy procedure)
研究者
Duygu Kilic
Director
TC Erciyes University