NCT07013682 PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy
| NCT ID | NCT07013682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-12-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-05-01 with a primary completion date of 2027-12-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Any condition that prevents venipuncture * Not willing to venous puncture * Current cancer treatment * History of radiation in the head-neck area
Contact & Investigator
Giovanni Salvi, DMD
PRINCIPAL INVESTIGATOR
University of Bern
Frequently Asked Questions
Who can join the NCT07013682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07013682 currently recruiting?
Yes, NCT07013682 is actively recruiting participants. Contact the research team at alexandra.staehli@unibe.ch for enrollment information.
Where is the NCT07013682 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07013682 clinical trial?
NCT07013682 is sponsored by University of Bern. The principal investigator is Giovanni Salvi, DMD at University of Bern. The trial plans to enroll 20 participants.