REGENFAST vs L-PRF in Periodontal Regeneration

NCT07430748 | Active Not Recruiting Early Phase 1

• 1 other identifier: REGENPRF_2025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Defects; Biomaterials; Regeneration

Keywords

polinucleotids; L-PRF; split-mouth; periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  Baseline (preoperative), 7 days, 14 days, 1 month, and 3 months postoperatively.

• Landry Wound Healing Index

  7 days and 14 days postoperatively.

Study Arms (2)

REGENFAST® Treatment

EXPERIMENTAL

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®)

L-PRF Treatment

ACTIVE COMPARATOR

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)

Interventions

Periodontal Regenerative Surgery (REGENFAST®) PROCEDURE

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.

REGENFAST® Treatment

Periodontal Regenerative Surgery (L-PRF) PROCEDURE

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.

L-PRF Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Facultade de Odontoloxía

Santiago de Compostela, A Coruña, 15782, Spain

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intra-patient comparison

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

ES (1)