PeriodontitisPRFSTEP2NCT07013682
PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy
A study testing PRF as adjunct to non-surgical mechanical debridement in people with Periodontitis and Periodontal Inflammation, run by University of Bern at 1 site in Switzerland.
Trial summary
Periodontitis is characterized by a chronic, multifactorial inflammatory process driven by dysbiotic plaque biofilms. It is recognized as the most common chronic inflammatory non-communicable disease in humans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Inflammation, Periodontal Attachment Loss
- What is being tested?
- PRF as adjunct to non-surgical mechanical debridement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to 24 Dec 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged ≥ 18 years
- Periodontitis stage II-IV, grade A/B/C, generalized
- Presence of at least 20 teeth (excluding wisdom teeth)
- Absence of removable dentures
- Patients willing to provide written informed consent and to complete the 6- month study follow-up
Who cannot join
- Patients already participating in other clinical trials
- Periodontal treatment in the previous 12 months
- Antibiotic treatment 3 months prior to study entry
- Antibiotic prophylaxis required for dental treatment
- Current use of any medication that may affect the clinical features of periodontitis
- Pregnant/lactating
Show all 10Show fewer
- Any condition that prevents venipuncture
- Not willing to venous puncture
- Current cancer treatment
- History of radiation in the head-neck area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Claude Imber, DMD contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Periodontology, University of Bern
Bern, 3010
Alexandra Stähli, MD, +41316840729-, alexandra.staehli@unibe.ch
Jean-Claude Imber, MD, +41 31 632 35 51, jean-claude.imber@unibe.ch
About this study
Official title: Platelet Rich Fibrin Adjunctive to Non-surgical Periodontal Therapy: a 6-month Split-mouth Randomized Controlled Clinical Trial
Periodontitis is characterized by a chronic, multifactorial inflammatory process driven by dysbiotic plaque biofilms. It is recognized as the most common chronic inflammatory non-communicable disease in humans. The advanced and severe forms of periodontitis have an estimated prevalence of 7.4%, while milder forms can affect up to 50% of the population.
If left untreated, periodontitis can lead to tooth loss. However, it is largely preventable and treatable with mechanical non-surgical periodontal therapy. To improve periodontal healing and thus clinical attachment gain after non-surgical therapy, adjunctive bioactive formulations such as enamel matrix derivatives, sodium hypochlorite, locally delivered antimicrobials, or hyaluronic acid have recently been proposed. However, these agents are non-autologous formulations and expensive.
Read more
Platelet-rich fibrin (PRF) acts as a scaffold that inhibits the early migration of epithelial cells into the periodontal tissues. Its regenerative properties are primarily due to its ability to promote angiogenesis. This ability is attributed to the 3D fibrin matrix, which can simultaneously transport several cytokines and growth factors. These include vascular endothelial growth factor (VEGF), insulin growth factor (IGF), transforming growth factor β1 (TGF-β1) and platelet-derived growth factor (PDGF). PRF further shows antibacterial properties and accelerates soft tissue healing. So far PRF is not routinely used in periodontal non-surgical therapy.
The aim of this 6-month, split-mouth randomized clinical trial including 20 patients is to test whether PRF can improve the results after non-surgical therapy.
Read the detailed description
The primary objective of this study is to determine whether scaling and root planing (SRP) combined with the application of a platelet-rich fibrin (PRF) membrane can improve clinical outcomes. Specific outcomes to be measured include reduction in probing pocket depth (PPD), gain in clinical attachment level (CAL), improvement in plaque index, gingival index, and minimization of gingival recession (GR) compared to SRP therapy alone after 3 and 6 months. Further patients reported pain outcomes as well as bacterial profiles and inflammatory markers will be checked.
Patients presenting with periodontitis stage II-IV will be included having at least 20 teeth.
The study includes multiple timepoints: a screening visit, a visit for full-mouth non-surgical treatment with and without PRF in a split-mouth design, a 7-day follow-up visit, a 3-month follow-up visit, and a final assessment 6 months after the non-surgical therapy.
- Being tested
- PRF as adjunct to non-surgical mechanical debridement, Control, non-surgical mechanical debridement alone
- Medical subject headings
- Periodontitis, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF as adjunct to non-surgical mechanical debridementBiological
Non-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, the PRF will be inserted in all pockets of the allocated side of the jaw in all pockets ≥ 5 mm.
Control, non-surgical mechanical debridement aloneBiological
Non-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, an empty sy will be inserted in all pockets of the allocated control side of the jaw in all pockets ≥ 5 mm.
| Study group | Role | What they receive |
|---|---|---|
| Control side | Sham comparator | After non-surgical mechanical debridement of all pockets ≥ 5 mm, an empty syringe will be inserted. Receives: Biological: Control, non-surgical mechanical debridement alone |
| Test side | Active comparator | After non-surgical mechanical debridement of all pockets ≥ 5 mm, PRF will be inserted. Receives: Biological: PRF as adjunct to non-surgical mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPD after 6 months
Changes in probing depths measured with a periodontal probe in mm from baseline to 6 months after non-surgical periodontal therapy
Measured: 6 months follow-up
Secondary outcomes (17)
Change in PPD after 3 months
Changes in probing depths measured with a periodontal probe in mm from baseline to 3 months after non-surgical periodontal therapy
Measured: 3 months follow-up
Change in clinical attachment level (CAL)
The distance in millimeters from the cement-enamel junction (CEJ) to the bottom of the periodontal pocket. This will be assessed using a periodontal probe with mm scale
Measured: 3 months and 6 months follow-up
Frequency of residual pockets
The number of probing depth of > 5 mm will be assessed
Measured: 3 months and 6 months follow-up
Full-mouth bleeding score (FMBS)
Percentage of tooth sites (six sites) revealing the presence of bleeding on probing to the bottom of the periodontal pocket. For this a periodontal probe with mm scale will be used, a score of 0% will represent perfect hygiene and 100% plaque on all surfaces (worst value)
Measured: Baseline, 3 months and 6 months follow-up
Gingival Recession (REC)
The distance in millimeters from the gingival margin to the cemento-enamel junction (CEJ). The measurements will be performed with a periodontal probe with a mm scale
Measured: Baseline, 3 months and 6 months follow-up
Comparison in PPD change between smokers and non-smokers
Differences in outcome measures will be assessed
Measured: 3 months and 6 months follow-up
Levels of periodontal bacteria
Levels of periodontal bacteria will assessed by multiplex Polymerase Chain Reaction
Measured: Baseline, 3 months and 6 months follow-up
Comparison of periodontal bacteria between smokers and non-smokers
Levels of periodontal bacteria will assessed by multiplex PCR
Measured: Baseline, 3 months and 6 months follow-up
Levels of Interleukin (IL)-1beta
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Levels of Matrix metalloproteinase (MMP)-8
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Levels of IL-8
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of IL-1beta
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of MMP-8
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of IL-8
Levels in gingival crevicular fluid will be assessed with ELISA assays
Measured: Baseline, 7 days, 3 months and 6 months follow-up
Antimicrobial activity of PRF
Remnants of PRF will be used for assessment of antimicrobial activity
Measured: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
Comparison between smokers and non-smokers in antimicrobial activity of PRF
Remnants of PRF will be used for assessment of antimicrobial activity
Measured: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
Patient reported pain outcomes
A visual analogue scale (100 mm) will be used for the left and right side of the jaw to quantify pain levels. 0 will be no pain at all and 100 mm the worst imaginable level of pain.
Measured: Each day from day 1 to 7 after non-surgical periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 May 2025
- Primary completion24 Dec 2027 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a split-mouth study. One side of the mouth (upper and lower jaw) will be treated with adjunctive PRF during non-surgical mechanical therapy and the other without.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Salvi, DMD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013682
- Sponsor's protocol ID
- PRF2
- Acronym
- PRFSTEP2
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin Adjunctive to Non-surgical Periodontal Therapy: a 6-month Split-mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07013682
- Acronym / sponsor ID
- PRFSTEP2 / PRF2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 10 Jun 2025 (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.
Periodontitis is characterized by a chronic, multifactorial inflammatory process driven by dysbiotic plaque biofilms. It is recognized as the most common chronic inflammatory non-communicable disease in humans. The advanced and severe forms of periodontitis have an estimated prevalence of 7.4%, while milder forms can affect up to 50% of the population.
If left untreated, periodontitis can lead to tooth loss. However, it is largely preventable and treatable with mechanical non-surgical periodontal therapy. To improve periodontal healing and thus clinical attachment gain after non-surgical therapy, adjunctive bioactive formulations such as enamel matrix derivatives, sodium hypochlorite, locally delivered antimicrobials, or hyaluronic acid have recently been proposed. However, these agents are non-autologous formulations and expensive.
Platelet-rich fibrin (PRF) acts as a scaffold that inhibits the early migration of epithelial cells into the periodontal tissues. Its regenerative properties are primarily due to its ability to promote angiogenesis. This ability is attributed to the 3D fibrin matrix, which can simultaneously transport several cytokines and growth factors. These include vascular endothelial growth factor (VEGF), insulin growth factor (IGF), transforming growth factor β1 (TGF-β1) and platelet-derived growth factor (PDGF). PRF further shows antibacterial properties and accelerates soft tissue healing. So far PRF is not routinely used in periodontal non-surgical therapy.
The aim of this 6-month, split-mouth randomized clinical trial including 20 patients is to test whether PRF can improve the results after non-surgical therapy.
Detailed description
The primary objective of this study is to determine whether scaling and root planing (SRP) combined with the application of a platelet-rich fibrin (PRF) membrane can improve clinical outcomes. Specific outcomes to be measured include reduction in probing pocket depth (PPD), gain in clinical attachment level (CAL), improvement in plaque index, gingival index, and minimization of gingival recession (GR) compared to SRP therapy alone after 3 and 6 months. Further patients reported pain outcomes as well as bacterial profiles and inflammatory markers will be checked.
Patients presenting with periodontitis stage II-IV will be included having at least 20 teeth.
The study includes multiple timepoints: a screening visit, a visit for full-mouth non-surgical treatment with and without PRF in a split-mouth design, a 7-day follow-up visit, a 3-month follow-up visit, and a final assessment 6 months after the non-surgical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a split-mouth study. One side of the mouth (upper and lower jaw) will be treated with adjunctive PRF during non-surgical mechanical therapy and the other without.
| Arm | Type | Receives |
|---|---|---|
| Control side | Sham comparator | Biological: Control, non-surgical mechanical debridement aloneAfter non-surgical mechanical debridement of all pockets ≥ 5 mm, an empty syringe will be inserted. |
| Test side | Active comparator | Biological: PRF as adjunct to non-surgical mechanical debridementAfter non-surgical mechanical debridement of all pockets ≥ 5 mm, PRF will be inserted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged ≥ 18 years
- Periodontitis stage II-IV, grade A/B/C, generalized
- Presence of at least 20 teeth (excluding wisdom teeth)
- Absence of removable dentures
- Patients willing to provide written informed consent and to complete the 6- month study follow-up
Key exclusion criteria (10 listed)
- Patients already participating in other clinical trials
- Periodontal treatment in the previous 12 months
- Antibiotic treatment 3 months prior to study entry
- Antibiotic prophylaxis required for dental treatment
- Current use of any medication that may affect the clinical features of periodontitis
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 |
|---|---|---|
| PRF as adjunct to non-surgical mechanical debridementNon-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, the PRF will be inserted in all pockets of the allocated side of the jaw in all pockets ≥ 5 mm. | Biological | Test side |
| Control, non-surgical mechanical debridement aloneNon-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, an empty sy will be inserted in all pockets of the allocated control side of the jaw in all pockets ≥ 5 mm. | Biological | Control side |
Primary outcome
Change in PPD after 6 months
Time frame: 6 months follow-up
Changes in probing depths measured with a periodontal probe in mm from baseline to 6 months after non-surgical periodontal therapy
17 secondary outcomes
Change in PPD after 3 months
Time frame: 3 months follow-up
Change in clinical attachment level (CAL)
Time frame: 3 months and 6 months follow-up
Frequency of residual pockets
Time frame: 3 months and 6 months follow-up
Full-mouth bleeding score (FMBS)
Time frame: Baseline, 3 months and 6 months follow-up
Gingival Recession (REC)
Time frame: Baseline, 3 months and 6 months follow-up
Comparison in PPD change between smokers and non-smokers
Time frame: 3 months and 6 months follow-up
Levels of periodontal bacteria
Time frame: Baseline, 3 months and 6 months follow-up
Comparison of periodontal bacteria between smokers and non-smokers
Time frame: Baseline, 3 months and 6 months follow-up
Levels of Interleukin (IL)-1beta
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Levels of Matrix metalloproteinase (MMP)-8
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Levels of IL-8
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of IL-1beta
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of MMP-8
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Comparison between smokers and non-smokers in levels of IL-8
Time frame: Baseline, 7 days, 3 months and 6 months follow-up
Antimicrobial activity of PRF
Time frame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
Comparison between smokers and non-smokers in antimicrobial activity of PRF
Time frame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
Patient reported pain outcomes
Time frame: Each day from day 1 to 7 after non-surgical periodontal therapy
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 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Jean-Claude Imber, DMD contact
Giovanni Salvi, DMD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF as adjunct to non-surgical mechanical debridement in people with Periodontitis and Periodontal Inflammation, run by University of Bern at 1 site in Switzerland.
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 10 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: looking for participants now, as of the sponsor's last update on 2 Jul 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Alexandra Stähli, DMD (+41 79 387 15 14, alexandra.staehli@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PPD after 6 months (time frame: 6 months follow-up). 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 2 Jul 2026.