Gingival Phenotype Thickening Using Injectable PRF Alone or Combined With a Semi-Surgical Approach: A Split-Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gingival Thickness (Ultrasonographic Measurement)
研究概览
简要总结
This randomized split-mouth clinical trial aims to evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in thickening thin gingival phenotype and improving soft tissue conditions around teeth.
Thin gingival tissue is an important risk factor for gingival recession and may negatively affect periodontal health and esthetic outcomes. This study investigates whether the use of i-PRF, obtained from the patient's own blood, can enhance gingival thickness and support tissue healing.
Following initial periodontal therapy, the procedure will be performed under local anesthesia. A minimally invasive approach will be applied to the gingival tissue, and i-PRF prepared from the patient's blood will be injected into the treatment area. The procedure will be repeated in multiple sessions at regular intervals. Patients will receive standard post-operative care and instructions.
Clinical parameters will be evaluated at follow-up visits, and gingival thickness will be measured using ultrasonography over a 6-month period.
Possible risks include mild pain, bleeding, infection, and temporary discomfort, all of which are manageable with routine clinical care.
This study is expected to contribute to the development of minimally invasive and biologically based treatment approaches, reduce the need for additional surgical procedures, and improve periodontal and esthetic outcomes.
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 (Participant)
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
- •Systemically healthy individuals aged ≥18 years
- •Non-smokers or light smokers (≤10 cigarettes per day)
- •Individuals with full-mouth plaque score (FMPS) <15% and full-mouth bleeding score (FMBS) <15%
- •Individuals with gingival thickness <0.8 mm in the mandibular anterior teeth to be treated
- •Periodontally healthy individuals with probing depth (PD) ≤3 mm in the mandibular anterior teeth
- •Absence of structural defects, crowns, or large restorations in the mandibular anterior teeth
- •Absence of missing or supernumerary teeth in the mandibular anterior region
- •No history of blood-borne infectious diseases
- •No systemic diseases or medical conditions
排除标准
- •Individuals under 18 years of age
- •Pregnancy or breastfeeding
- •Presence of periodontal pockets >4 mm
- •Presence of structural defects, crowns, or large restorations in the teeth
- •Presence of systemic diseases or coagulation disorders
- •Use of anticoagulant medications
- •Ongoing orthodontic treatment with active tooth movement
- •Use or history of medications affecting periodontal tissues (e.g., immunosuppressive drugs, calcium channel blockers, anticonvulsants)
- •History of periodontal surgery in the area to be treated
研究组 & 干预措施
Injectable Platelet-Rich Fibrin (i-PRF) Alone (control)
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique (Procedure)
Injectable Platelet-Rich Fibrin (i-PRF) with Minimally Invasive Technique (test)
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) with and without Minimally Invasive Technique (Procedure)
结局指标
主要结局
Gingival Thickness (Ultrasonographic Measurement)
时间窗: 6 month
Assessment of gingival thickness using ultrasonography to evaluate changes in soft tissue thickness. Measurements will be performed at baseline, 1 month, 3 months, and 6 months.
次要结局
未报告次要终点
研究者
Mustafa Tunali
Prof.Dr
Çanakkale Onsekiz Mart University