REGENFAST vs L-PRF in Periodontal Regeneration

Comparison of REGENFAST and L-PRF in Bilateral Periodontal Defects: A Split-Mouth Pilot Clinical Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Regeneration; Periodontal Defects; Biomaterials
• Intervention / Treatment: Procedure: Periodontal Regenerative Surgery (REGENFAST®); Procedure: Periodontal Regenerative Surgery (L-PRF)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15782
      • Facultade de Odontoloxía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Periodontal 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.
Active Comparator: 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.	Procedure: Periodontal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level (CAL) Gain	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.	Baseline (preoperative) 1 month postoperative 3 months postoperative (primary analysis time point)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Recession Depth (GRD)	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.	Baseline (preoperative), 1 month, and 3 months postoperatively.
Probing Depth (PD)	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.	Baseline (preoperative), 1 month, and 3 months postoperatively.
Bleeding on Probing (BoP)	Indicator of soft tissue inflammation, recorded as presence or absence of bleeding within 15 seconds after probe insertion. Visual inspection under standardized probing conditions.	Baseline (preoperative), 1 month, and 3 months postoperatively.
Total Surgical Time	Duration of the surgical procedure from the first incision to complete flap closure. Recorded in minutes using a digital chronometer.	Intraoperative (single measurement).
Clinical Healing Time (Complete Epithelialization)	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.	Daily evaluation until complete healing or up to 14 days postoperatively.
Radiographic Changes	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).	Baseline (preoperative) and 3 months postoperatively.
Gingival Inflammation Index	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.	Baseline (preoperative), 7 days, 14 days, 1 month, and 3 months postoperatively.
Landry Wound Healing Index	Qualitative assessment of wound healing based on color, exudate, granulation tissue, and epithelialization. Scored from 1 (very poor) to 5 (excellent) healing.	7 days and 14 days postoperatively.

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: L-PRF; periodontal regeneration; split-mouth; polinucleotids
• Other Study ID Numbers: REGENPRF_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No