Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06753396

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

On this page

AI-Summary

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

Eligible

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
Not Eligible

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

AI-Screening

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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

Kütahya, Turkey (Türkiye), 43100

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Research Team

B

Berceste Güler Ayyıldız

S

Seyma Eken

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Nai H Faour, Suleiman Dayoub, Mohammad Y Hajeer

https://pubmed.ncbi.nlm.nih.gov/35607316

Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial.

Zeliha Betul Ozsagir, Ebru Saglam, Berza Sen Yilmaz...

https://pubmed.ncbi.nlm.nih.gov/31912532

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...

https://pubmed.ncbi.nlm.nih.gov/19719741

Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis.

Lorenzo Tavelli, Shayan Barootchi, Gustavo Avila-Ortiz...

https://pubmed.ncbi.nlm.nih.gov/32710810