PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this 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.
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
PRF as adjunct to non-surgical mechanical debridement
Biological/VaccineNon-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 alone
Biological/VaccineNon-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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Control sideSham comparator 1 intervention
Group B: Test sideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 months follow-upSecondary outcomes
1
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
Time frame
3 months follow-up2
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
Time frame
3 months and 6 months follow-up3
Frequency of residual pockets
The number of probing depth of \> 5 mm will be assessed
Time frame
3 months and 6 months follow-up4
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)
Time frame
Baseline, 3 months and 6 months follow-upSponsors and contacts
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Source ClinicalTrials.gov