RegenerationEarly Phase 1NCT07430748
REGENFAST vs L-PRF in Periodontal Regeneration
A Early Phase 1 study testing Periodontal Regenerative Surgery (REGENFAST®) and Periodontal Regenerative Surgery (L-PRF) in people with Regeneration and Periodontal Defects, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regeneration, Periodontal Defects, Biomaterials
- What is being tested?
- Periodontal Regenerative Surgery (REGENFAST®) and Periodontal Regenerative Surgery (L-PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 31 May 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Regeneration, Periodontal Defects, Biomaterials
- Being tested
- Periodontal Regenerative Surgery (REGENFAST®), Periodontal Regenerative Surgery (L-PRF)
- Keywords
- polinucleotids, L-PRF, split-mouth, periodontal regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Regenerative Surgery (REGENFAST®)Procedure or surgery
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)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Periodontal Regenerative Surgery (L-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative) 1 month postoperative 3 months postoperative (primary analysis time point)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (preoperative), 1 month, 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.
Measured: 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.
Measured: 7 days and 14 days postoperatively.
Total Surgical Time
Duration of the surgical procedure from the first incision to complete flap closure. Recorded in minutes using a digital chronometer.
Measured: 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.
Measured: 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).
Measured: Baseline (preoperative) and 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intra-patient comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430748
- Sponsor's protocol ID
- REGENPRF_2025
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of REGENFAST and L-PRF in Bilateral Periodontal Defects: A Split-Mouth Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT07430748
- Acronym / sponsor ID
- REGENPRF_2025
- Conditions
- Regeneration, Periodontal Defects, Biomaterials
- Keywords
- polinucleotids, L-PRF, split-mouth, periodontal regeneration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intra-patient comparison
| Arm | Type | Receives |
|---|---|---|
| REGENFAST® Treatment | Experimental | Procedure: Periodontal Regenerative Surgery (REGENFAST®)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. |
| L-PRF Treatment | Active comparator | Procedure: Periodontal Regenerative Surgery (L-PRF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | REGENFAST® Treatment |
| 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. | Procedure or surgery | L-PRF Treatment |
Primary outcome
Clinical Attachment Level (CAL) Gain
Time frame: 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.
8 secondary outcomes
Gingival Recession Depth (GRD)
Time frame: Baseline (preoperative), 1 month, and 3 months postoperatively.
Probing Depth (PD)
Time frame: Baseline (preoperative), 1 month, and 3 months postoperatively.
Bleeding on Probing (BoP)
Time frame: Baseline (preoperative), 1 month, and 3 months postoperatively.
Gingival Inflammation Index
Time frame: Baseline (preoperative), 7 days, 14 days, 1 month, and 3 months postoperatively.
Landry Wound Healing Index
Time frame: 7 days and 14 days postoperatively.
Total Surgical Time
Time frame: Intraoperative (single measurement).
Clinical Healing Time (Complete Epithelialization)
Time frame: Daily evaluation until complete healing or up to 14 days postoperatively.
Radiographic Changes
Time frame: Baseline (preoperative) and 3 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Periodontal Regenerative Surgery (REGENFAST®) and Periodontal Regenerative Surgery (L-PRF) in people with Regeneration and Periodontal Defects, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (CAL) Gain (time frame: Baseline (preoperative) 1 month postoperative 3 months postoperative (primary analysis time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.