REGENFAST vs L-PRF in Periodontal Regeneration

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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