The Effect of Injectable Platelet-Rich Fibrin and Low-Level Laser Therapy on Graft Shrinkage in Free Gingival Grafts: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Graft Area Shrinkage (%)
研究概览
简要总结
This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Free gingival grafts are commonly used to increase the width of keratinized tissue around teeth, but the graft often shrinks during healing. In this study, patients will receive standard free gingival graft surgery with or without additional i-PRF or laser therapy. The goal is to determine whether these treatments improve healing and help maintain the size of the graft.
详细描述
This randomized controlled clinical trial investigates the effects of injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) on the shrinkage of free gingival grafts (FGG) used to treat gingival recession. Free gingival grafting is commonly performed to increase the width of keratinized tissue around teeth, but shrinkage during healing can reduce clinical outcomes.
The study included 48 systemically healthy adult patients with Cairo Class I gingival recession in mandibular anterior teeth. Participants were randomly assigned to one of three groups: control (FGG alone), i-PRF (FGG + platelet-rich fibrin), or LLLT (FGG + low-level laser therapy). Ethical approval was obtained from the Clinical Research Ethics Committee of Inonu University (Protocol No: 2024/84), and all participants provided written informed consent. The study protocol was registered at ClinicalTrials.gov (NCT06744270) and conducted according to CONSORT 2010 guidelines.
All patients received preoperative periodontal treatment, including plaque removal and oral hygiene instructions. Free gingival grafts were harvested from the palatal region and adapted to the recipient site, then stabilized with sutures. In the i-PRF group, autologous platelet-rich fibrin gel was applied to the graft surface. In the LLLT group, laser therapy was applied immediately after surgery and on postoperative days 3, 5, 7, and 14. The control group received no additional treatment beyond standard grafting.
Postoperative care included use of a periodontal dressing, chlorhexidine mouthwash, analgesics as needed, and oral hygiene instructions after suture removal. Clinical evaluations included gingival recession depth, keratinized tissue height, probing depth, clinical attachment level, and graft area measurements at baseline, 1, 3, and 6 months. Edema, erythema, and patient-reported pain were also assessed during follow-up.
The primary outcome of the study was graft shrinkage, calculated as the percentage decrease in graft area over time. Secondary outcomes included clinical parameters and patient-reported postoperative morbidity. All measurements were performed by calibrated, blinded examiners to ensure reliability.
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
- Triple (Participant, 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
- 否
入选标准
- •Age > 18 years.
- •Systemically healthy.
- •Cairo Class I gingival recession in vital mandibular anterior incisors.
- •No caries or restorations in the relevant teeth.
- •Keratinized gingiva height < 2 mm in the included teeth.
- •Plaque Index (PI) <
- •Gingival Index (GI) < 1.
排除标准
- •Active periodontal disease or probing depth > 3 mm.
- •Use of medications that could prevent surgery or affect wound healing.
- •Pregnancy or breastfeeding.
- •History of periodontal surgery in the working area.
- •Active smokers.
- •Current orthodontic treatment.
研究组 & 干预措施
Control Group
Patients receive free gingival graft only without additional treatment.
干预措施: Free Gingival Graft (FGG) (Procedure)
i-PRF group
Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.
干预措施: Free Gingival Graft (FGG) (Procedure)
i-PRF group
Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.
干预措施: Low-Level Laser Therapy (LLLT) (Device)
LLLT Group
Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14.
干预措施: Free Gingival Graft (FGG) (Procedure)
LLLT Group
Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14.
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) (Biological)
结局指标
主要结局
Graft Area Shrinkage (%)
时间窗: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in graft surface area, expressed as percentage shrinkage from baseline. Standardized clinical photographs taken at baseline and at postoperative 1, 3, and 6 months were analyzed using calibrated digital image analysis software (ImageJ). The graft borders were traced, and surface area (mm²) was calculated. Each measurement was repeated three times, and the mean value was used. Shrinkage percentage was calculated using the formula: Shrinkage % = \[(baseline area - follow-up area) / baseline area\] × 100.
Root Coverage Percentage (%)
时间窗: Baseline and 6 months postoperatively.
Percentage of root coverage obtained at 6 months. Root coverage was calculated from changes in gingival recession depth (RD) using the formula: Root Coverage % = \[(baseline RD - RD at 6 months) / baseline RD\] × 100. RD was defined as the distance from the CEJ to the gingival margin and measured using a manual periodontal probe.
Gingival Recession Depth (RD)
时间窗: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in gingival recession depth measured in millimeters.
Keratinized Tissue Height (KTH)
时间窗: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in keratinized tissue height measured in millimeters.
次要结局
- Probing Depth (PD)(Baseline, 1 month, 3 months, and 6 months postoperatively.)
- Clinical Attachment Level (CAL)(Baseline, 1 month, 3 months, and 6 months postoperatively.)
- Oedema Score in the Recipient Site(Postoperative days 3, 5, 7, 14, 21, and 28.)
- Erythema Score in the Recipient Site(Postoperative days 3, 5, 7, 14, 21, and 28.)
- Pain Intensity (VAS Score)(First postoperative week.)
- Analgesic Consumption(First postoperative week.)
研究者
Esra Bozkurt
Assistant Professor
Kahramanmaras Sutcu Imam University