Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of Graft Shrinkage
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effects of injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) gel on clinical healing and graft shrinkage when used in addition to Free Gingival Graft (FGG) surgery. The study involves patients with gingival recession and insufficient keratinized tissue. Participants will be randomly divided into three groups: FGG with i-PRF application, FGG with HA gel application, Conventional FGG alone (Control group). The main goal is to compare the amount of graft shrinkage and evaluate clinical wound healing parameters between these groups over a 3-month follow-up period.
详细描述
Gingival recession and inadequate keratinized tissue are common mucogingival problems that can compromise periodontal health. Free gingival graft (FGG) therapy is considered the gold standard for increasing keratinized tissue; however, dimensional shrinkage of the graft during the healing process remains a significant clinical challenge. The survival and success of the graft depend heavily on rapid revascularization.
This randomized controlled clinical trial aims to investigate whether the adjunctive use of biological agents can minimize graft shrinkage and enhance soft tissue healing.
All eligible patients will initially receive non-surgical Phase 1 periodontal therapy, including professional plaque removal and oral hygiene instructions.
During the surgical phase, a partial-thickness recipient bed will be prepared in the mandibular incisor region. A free gingival graft of approximately 1 to 1.5 mm thickness will be harvested from the palatal donor site.
Depending on the randomization assignment:
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
- Single (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
- 否
入选标准
- •Individuals aged 18 years or older.
- •Systemically healthy patients with no contraindications for periodontal surgery.
- •Patients presenting with gingival recession and/or inadequate width of keratinized tissue requiring Free Gingival Graft (FGG) therapy.
- •Non-smokers.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients with systemic diseases that may affect wound healing (e.g., uncontrolled diabetes mellitus, autoimmune disorders).
- •Pregnant or lactating individuals.
- •Patients with poor oral hygiene.
- •Current smokers or tobacco users.
- •Patients who have received periodontal surgery in the designated surgical area within the last 6 months.
研究组 & 干预措施
FGG + i-PRF
Free gingival graft combined with injectable platelet-rich fibrin (i-PRF).
干预措施: Free Gingival Graft with i-PRF (Procedure)
FGG + Hyaluronic Acid
Free gingival graft combined with 0.8% hyaluronic acid gel.
干预措施: Free Gingival Graft with Hyaluronic Acid (Procedure)
Conventional FGG (Control)
Conventional free gingival graft applied without any additional biological agents.
干预措施: Free gingival graft (Procedure)
结局指标
主要结局
Percentage of Graft Shrinkage
时间窗: Baseline, 1 month, and 3 months post-operation
Graft shrinkage will be evaluated by calculating the surface area of the graft in square millimeters using standardized clinical photographs and ImageJ software. The percentage of shrinkage is calculated with the formula: ((Immediate post-operative graft area - Follow-up graft area ) / Immediate post-operative graft area) x 100.
次要结局
- Probing Depth (PD)(Baseline, 1 month, and 3 months post-operation)
- Wound Healing Index(7 days, 14 days, 21 days, 1 month, and 3 months post-operation)
- Root Coverage Esthetic Score (RES)(3 months post-operation)
- Clinical Attachment Level (CAL)(Baseline, 1 month, and 3 months post-operation)
- Gingival Recession Height(Baseline, 1 month, and 3 months post-operation.)
- Keratinized Tissue Height(Baseline, 1 month, and 3 months post-operation.)
- Keratinized Tissue Thickness(Baseline and 3 months post-operation.)