Experimentally induced peri-implant mucositis. A clinical study in humans.
R Pontoriero, M P Tonelli, G Carnevale...
https://pubmed.ncbi.nlm.nih.gov/7640340/Actively Recruiting
Led by University of Bern · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
Researchers are evaluating the use of platelet-rich fibrin PRF, a natural blood-derived product rich in growth factors, to enhance healing and bone regeneration in peri-implantitis, a chronic infection causing inflammation and bone loss around dental implants. This study aims to compare surgical cleaning of peri-implantitis defects combined with PRF application to surgical cleaning alone, assessing improvements in tissue regeneration and healing. The trial is randomized and evaluates outcomes over 12 months using clinical and radiographic measures. The study involves two groups one receiving open flap debridement with a chemo-electric device plus PRF clots and membranes applied into the defect, and the other receiving the same debridement and detoxification without PRF. Blood is drawn for PRF preparation in the treatment group, and after surgical cleaning, the flap is closed in both groups. Implants with similar defect sizes are randomly assigned to either group for comparison. Participants will undergo clinical evaluations including radiographic defect fill, probing pocket depth, bleeding on probing, and soft tissue healing indices at baseline and after 12 months. Patient-reported pain is also measured using a visual analog scale shortly after surgery. The study includes monitoring of keratinized tissue width and composite clinical indices to assess treatment effects. The total participation period includes follow-ups at multiple time points within one year post-surgery.
CONDITIONS
Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF)
A
Alexandra Stähli, MD
J
Jean-Claude Imber, MD
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University of Bern
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo surgical treatment involving open flap debridement with implant surface cleaning. Depending on group assignment, PRF clots and membranes may be applied to the defect before closing the flap. Soft tissue healing is monitored shortly after surgery.
3 visits (2 days, 7 days, and 14 days post-surgery)
Duration - 12 months
Participants return for follow-up visits to assess radiographic defect fill, clinical parameters including probing pocket depth and bleeding on probing, keratinized tissue width, and patient-reported outcomes over a period of 12 months after surgery.
2 visits (baseline and 12-month follow-up)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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