An interventional study of PRF as adjunct to non-surgical mechanical debridement and Control, non-surgical mechanical debridement alone in Periodontitis, Periodontal Inflammation and Periodontal Attachment Loss, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After non-surgical mechanical debridement of all pockets ≥ 5 mm, an empty syringe will be inserted.
Biological: Control, non-surgical mechanical debridement alone
After non-surgical mechanical debridement of all pockets ≥ 5 mm, PRF will be inserted.
Biological: PRF as adjunct to non-surgical mechanical debridement
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.
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.
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-up
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-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
Time frame: 3 months and 6 months follow-up
Frequency of residual pockets
The number of probing depth of \> 5 mm will be assessed
Time frame: 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)
Time frame: 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
Time frame: Baseline, 3 months and 6 months follow-up
Comparison in PPD change between smokers and non-smokers
Differences in outcome measures will be assessed
Time frame: 3 months and 6 months follow-up
Levels of periodontal bacteria
Levels of periodontal bacteria will assessed by multiplex Polymerase Chain Reaction
Time frame: 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
Time frame: Baseline, 3 months and 6 months follow-up
Levels of Interleukin (IL)-1beta
Levels in gingival crevicular fluid will be assessed with ELISA assays
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Remnants of PRF will be used for assessment of antimicrobial activity
Time frame: 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.
Time frame: Each day from day 1 to 7 after non-surgical periodontal therapy
Plan to share: No
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