Comparison of REGENFAST and L-PRF in Bilateral Periodontal Defects: A Split-Mouth Pilot Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level (CAL) Gain
研究概览
简要总结
Introduction: Periodontal disease causes the progressive loss of supporting structures of the teeth, resulting in bone and soft tissue defects that compromise function and aesthetics. Regenerative periodontal therapy aims to restore these tissues through techniques that stimulate bone and connective tissue regeneration. Among the biomaterials used, Leukocyte- and Platelet-Rich Fibrin (L-PRF) has become widely applied due to its autologous origin, simplicity of preparation, and capacity to release growth factors that promote angiogenesis and wound healing. However, the regenerative potential of new bioactive materials such as REGENFAST®, a combination of polynucleotides and hyaluronic acid, has recently gained attention. Polynucleotides act as biological stimulators that enhance fibroblast activity and tissue oxygenation, while hyaluronic acid improves extracellular matrix remodeling and hydration. Although preclinical data suggest beneficial effects of REGENFAST® in soft and hard tissue repair, direct clinical comparisons with L-PRF in periodontal regeneration remain limited.
Objectives: The main objective is to evaluate and compare the clinical and radiographic efficacy of REGENFAST® and L-PRF in the treatment of bilateral periodontal defects.
Specific objectives include:
- Assessing the gain in clinical attachment level (CAL) at 3 months postoperatively as the primary outcome.
- Comparing changes in probing depth, gingival recession, bleeding on probing, and gingival inflammation index.
- Evaluating wound healing using the Landry Healing Index and recording total surgical and epithelialization times.
- Assessing radiographic bone density changes between baseline and 3 months. Patient inclusion will be based on predefined inclusion and exclusion criteria to ensure homogeneity and comparability.
Material and methods: A randomized, split-mouth pilot clinical trial will be conducted in patients presenting bilateral periodontal defects. Each subject will receive REGENFAST® on one site and L-PRF on the contralateral site, assigned by computer-generated randomization. Following local anesthesia, full-thickness flaps will be raised, and defects will be debrided and conditioned. The respective biomaterial will then be applied, and the flaps will be repositioned and sutured. Postoperative evaluations will occur at 7 days, 1 month, and 3 months, recording clinical parameters and radiographic outcomes. Data will be analyzed using paired t-tests with a significance level of p<0.05. The study will adhere to the Declaration of Helsinki and Good Clinical Practice guidelines, with informed consent obtained from all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient will be unaware of which site receives REGENFAST® or L-PRF, while the clinician performing the procedure will know the allocation. This ensures that patient-reported outcomes, such as pain and satisfaction, are not biased by knowledge of the treatment received.
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
- •Adult patients (≥18 years old) in good general health (ASA I-II).
- •Bilateral gingival recessions or symmetrical bone defects.
- •Absence of active infection or inflammation.
- •Good oral hygiene level (Plaque Index <20%).
- •Signed informed consent and commitment to follow-up.
排除标准
- •Systemic diseases that impair healing (uncontrolled diabetes, immunodeficiency, etc.).
- •Periodontal or antibiotic treatment within the last 6 months.
- •Smokers (>10 cigarettes/day).
- •Pregnancy or breastfeeding.
- •Allergy or hypersensitivity to REGENFAST® or surgical materials.
- •Use of medication affecting healing (corticosteroids, immunosuppressants, bisphosphonates).
- •Lack of availability to attend follow-up visits.
研究组 & 干预措施
REGENFAST® Treatment
This arm includes the treatment of periodontal defects using REGENFAST®, a combination of polynucleotides and hyaluronic acid. The biomaterial is applied to the defect site following standard minimally invasive surgical procedures, aiming to promote tissue regeneration, reduce inflammation, and accelerate wound healing. Postoperative follow-up will assess clinical and radiographic outcomes at defined intervals.
干预措施: Periodontal Regenerative Surgery (REGENFAST®) (Procedure)
L-PRF Treatment
This arm involves the treatment of periodontal defects using Leukocyte-Platelet Rich Fibrin (L-PRF). L-PRF is prepared from the patient's autologous blood and applied to the defect site following minimally invasive periodontal surgery. This treatment is intended to enhance angiogenesis, improve tissue regeneration, and support faster wound healing. Clinical and radiographic evaluations will be conducted at scheduled follow-up visits.
干预措施: Periodontal Regenerative Surgery (L-PRF) (Procedure)
结局指标
主要结局
Clinical Attachment Level (CAL) Gain
时间窗: Baseline (preoperative) 1 month postoperative 3 months postoperative (primary analysis time point)
To evaluate the gain in Clinical Attachment Level (CAL) at the site treated with REGENFAST® compared to the site treated with L-PRF, 3 months after surgery. This parameter serves as the main indicator of periodontal tissue regeneration and reduction of gingival recession.
次要结局
- Gingival Recession Depth (GRD)(Baseline (preoperative), 1 month, and 3 months postoperatively.)
- Probing Depth (PD)(Baseline (preoperative), 1 month, and 3 months postoperatively.)
- Bleeding on Probing (BoP)(Baseline (preoperative), 1 month, and 3 months postoperatively.)
- Gingival Inflammation Index (Löe and Silness, 1963)(Baseline (preoperative), 7 days, 14 days, 1 month, and 3 months postoperatively.)
- Landry Wound Healing Index (Landry et al., 1988)(7 days and 14 days postoperatively.)
- Total Surgical Time(Intraoperative (single measurement).)
- Clinical Healing Time (Complete Epithelialization)(Daily evaluation until complete healing or up to 14 days postoperatively.)
- Radiographic Changes(Baseline (preoperative) and 3 months postoperatively.)
研究者
Mario Pérez Sayáns
Professor
University of Santiago de Compostela