Evaluation of the Effect of Injectable Platelet-Rich Fibrin on Peri-Implant Soft Tissue Phenotype
Led by Kutahya Health Sciences University · Updated on 2025-09-11
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
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What this Trial Is About
Researchers are studying the effect of injectable platelet-rich fibrin on the soft tissue around dental implants in patients with insufficient peri-implant soft tissue. This study focuses on improving the keratinized mucosa width and mucosal thickness, which are important for implant health and appearance. Injectable platelet-rich fibrin, a bioactive agent rich in growth factors, has shown promise in supporting tissue regeneration around teeth, but its use around implants has not been previously explored.
The study involves 80 systemically healthy, non-smoking patients over 18 years old who have limited peri-implant keratinized mucosa and mucosal thickness. Participants are divided into two groups based on their mucosa thickness: thin or thick phenotype. All patients receive the same procedure where injectable platelet-rich fibrin, prepared from their own blood, is applied subgingivally and submucosally around the implant sites. This treatment is repeated once a month for three months.
Participants will undergo clinical evaluations including plaque and gingival indices, attachment loss, bleeding on probing, and measurements of keratinized mucosa and mucosal thickness. Standardized photographs and esthetic scoring will be performed before treatment and at 1, 3, 6, and 12 months after. The main outcomes measured are the width of keratinized mucosa and mucosal thickness around the implants over one year, along with esthetic improvements. This monitoring helps assess the potential benefits of the treatment on peri-implant soft tissue health and appearance.
CONDITIONS
Brief Title
The Effect of Injectable Platelet-Rich Fibrin in Peri-implant Soft Tissue
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Be over 18 years old
Have no systemic disease
Smoke fewer than 10 cigarettes per day
Have peri-implant keratinized mucosa width less than 2 mm
Have peri-implant mucosal thickness less than 2 mm
You will not qualify if you...
Be outside the defined age group
Have any systemic contraindication for periodontal surgery
Smoke more than 10 cigarettes per day
Have adequate peri-implant keratinized mucosa width and mucosal thickness
Be pregnant
Take medication that suppresses the immune system or impairs healing
Take medication that impairs bleeding conditions
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive injectable platelet-rich fibrin applied subgingivally and submucosally to the peri-implant soft tissue to improve tissue phenotype.
3 visits spaced 1 month apart
Follow-up
Duration - 12 months
Participants are monitored with standardized photographs and clinical assessments of peri-implant soft tissue phenotype over 12 months after treatment.
Visits at 1, 3, 6, and 12 months after treatment completion
Trial Site Locations
Total: 1 location
1
Kütahya Health Sciences University Faculty of Dentistry
Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial.
Five-year evaluation of the influence of keratinized mucosa on peri-implant soft-tissue health and stability around implants supporting full-arch mandibular fixed prostheses.
Alexander René Schrott, Monik Jimenez, Jae-Woong Hwang...