Clinical trial NCT07013682: PRF in Step 2 Periodontal Therapy
Official title: Platelet Rich Fibrin Adjunctive to Non-surgical Periodontal Therapy: a 6-month Split-mouth Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Inflammation
Periodontal Attachment Loss
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in PPD after 6 months
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Change in PPD after 3 months
timeFrame: 3 months follow-up
measure: Change in clinical attachment level (CAL)
timeFrame: 3 months and 6 months follow-up
measure: Frequency of residual pockets
timeFrame: 3 months and 6 months follow-up
measure: Full-mouth bleeding score (FMBS)
timeFrame: Baseline, 3 months and 6 months follow-up
measure: Gingival Recession (REC)
timeFrame: Baseline, 3 months and 6 months follow-up
measure: Comparison in PPD change between smokers and non-smokers
timeFrame: 3 months and 6 months follow-up
measure: Levels of periodontal bacteria
timeFrame: Baseline, 3 months and 6 months follow-up
measure: Comparison of periodontal bacteria between smokers and non-smokers
timeFrame: Baseline, 3 months and 6 months follow-up
measure: Levels of Interleukin (IL)-1beta
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Levels of Matrix metalloproteinase (MMP)-8
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Levels of IL-8
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Comparison between smokers and non-smokers in levels of IL-1beta
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Comparison between smokers and non-smokers in levels of MMP-8
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Comparison between smokers and non-smokers in levels of IL-8
timeFrame: Baseline, 7 days, 3 months and 6 months follow-up
measure: Antimicrobial activity of PRF
timeFrame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
measure: Comparison between smokers and non-smokers in antimicrobial activity of PRF
timeFrame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline
measure: Patient reported pain outcomes
timeFrame: Each day from day 1 to 7 after non-surgical periodontal therapy
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Periodontology, University of Bern
Study officials:
affiliation: University of Bern
name: Giovanni Salvi, DMD
role: PRINCIPAL_INVESTIGATOR
References: