Biomaterials, Periodontal Defects, Regeneration
Conditions
Keywords
polinucleotids, L-PRF, split-mouth, periodontal regeneration
Brief summary
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.
Interventions
PROCEDUREPeriodontal Regenerative Surgery (REGENFAST®)
In this arm, periodontal defects are treated with REGENFAST®, a biomaterial composed of polynucleotides and hyaluronic acid designed to promote tissue regeneration, reduce inflammation, and enhance wound healing. After thorough debridement of the defect, REGENFAST® is applied following the manufacturer's protocol. The treated site is then covered with a mucoperiosteal flap and sutured. This arm aims to evaluate the clinical and biological effects of REGENFAST® on periodontal tissue healing and regeneration compared to L-PRF.
PROCEDUREPeriodontal Regenerative Surgery (L-PRF)
In this arm, the contralateral periodontal defect in the same patient is treated with Leukocyte- and Platelet-Rich Fibrin (L-PRF), an autologous platelet concentrate obtained from the patient's venous blood by centrifugation without anticoagulants. The resulting fibrin membrane is placed directly into the prepared periodontal defect to stimulate angiogenesis and soft tissue repair through the sustained release of growth factors. This arm serves as the active comparator to assess differences in regenerative outcomes relative to REGENFAST® treatment.
Sponsors
University of Santiago de Compostela
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Intra-patient comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) Gain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Recession Depth (GRD) | Baseline (preoperative), 1 month, and 3 months postoperatively. | Distance from the cementoenamel junction to the gingival margin. Measured using a calibrated UNC-15 periodontal probe with 0.5 mm precision, under standardized conditions. |
| Probing Depth (PD) | Baseline (preoperative), 1 month, and 3 months postoperatively. | Distance from the gingival margin to the base of the sulcus or periodontal pocket. Measured using a calibrated UNC-15 periodontal probe with uniform pressure and technique across all evaluations. |
| Bleeding on Probing (BoP) | Baseline (preoperative), 1 month, and 3 months postoperatively. | Indicator of soft tissue inflammation, recorded as presence or absence of bleeding within 15 seconds after probe insertion. Visual inspection under standardized probing conditions. |
| Gingival Inflammation Index | Baseline (preoperative), 7 days, 14 days, 1 month, and 3 months postoperatively. | Clinical assessment of gingival inflammation on a 0-3 ordinal scale (0: no inflammation; 3: severe inflammation with spontaneous bleeding). Visual scoring by a blinded examiner. |
| Landry Wound Healing Index | 7 days and 14 days postoperatively. | Qualitative assessment of wound healing based on color, exudate, granulation tissue, and epithelialization. Scored from 1 (very poor) to 5 (excellent) healing. |
| Total Surgical Time | Intraoperative (single measurement). | Duration of the surgical procedure from the first incision to complete flap closure. Recorded in minutes using a digital chronometer. |
| Clinical Healing Time (Complete Epithelialization) | Daily evaluation until complete healing or up to 14 days postoperatively. | Time required for complete epithelialization of the surgical site without signs of inflammation or exudate. Direct clinical observation by the operator and digital photographic documentation. |
| Radiographic Changes | Baseline (preoperative) and 3 months postoperatively. | Assessment of bone density and reduction of the radiographic defect in the treated area. Standardized periapical radiographs (parallel technique) analyzed using digital densitometry software (gray scale units). |
Countries
Spain
Outcome results
None listed