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Clinical Trials in Turkey / NCT06753396
Recruiting Not applicable

The Effect of Injectable Platelet-Rich Fibrin in Peri-implant Soft Tissue

NCT06753396 · tracked via the Priya Life Science Turkey tracker
Sponsor
Kutahya Health Sciences University
Phase
Not applicable
Started
2022-12-15
Last updated
2025-09-11

Condition(s) studied

Peri-Implant Tissues

Investigational drug(s) / intervention(s)

Platelet rich fibrin

Platelet rich fibrin: The injectable platelet rich fibrin will be integrated into the tissue by subgingival and submucosal application to the keratinized gingiva of the implant sites with insufficient peri-implant soft tissue phenotype. Then, the prepared injectable platelet rich fibrin will be injected into the mucogingival junction apical to the keratinized gingival site. This procedure will be repeated 3 times in total, 1 time in 30 days for 3 months.

Study summary

An inadequate amount of peri-implant soft tissue results in more plaque accumulation around the implants, peri-implant mucositis, marginal bone loss, mucosal recession, and/or attachment loss. In the literature, there are studies evaluating the application of injectable platelet-rich fibrin to the gingiva and oral mucosa around teeth, but injectable platelet-rich fibrin application around implants has not been encountered. This study aimed to evaluate the effect of subgingival and submucosal application of injectable platelet-rich fibrin on peri-implant soft tissue phenotype in patients with inadequate peri-implant soft tissue phenotype.The study will include 80 systemically healthy and non-smoking patients/implants older than 18 years of age with insufficient peri-implant keratinized mucosa width and mucosal thickness who applied to Kütahya University of Health Sciences, Faculty of Dentistry, Department of Periodontology. There are two study groups according to peri-implant mucosa phenotype: Thin phenotype and thick phenotype. All patients will undergo the same procedure of injectable platelet-rich fibrin application

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. be over 18 years old 2. The patient does not have any systemic disease 3. Patients who do not smoke or who smoke less than 10 cigarettes 4. Peri-implant keratinized mucosa width less than 2 mm 5. Peri-implant mucosal thickness less than 2 mm Exclusion Criteria: 1. Being out of the defined age group 2. Any systematic contraindication for periodontal surgery 3. Patients who smoke more than 10 cigarettes per day 4. Patients with adequate peri-implant keratinized mucosa width and mucosal thickness 5. Pregnancy 6. Patients taking medication that suppresses the immune system or impairs healing 7. Patients taking medication that impairs the bleeding condition

Primary outcome measure(s)

  • Peri-implant keratinized mucosa width — 1-year follow-up of all implants
    To measure peri-implant keratinized mucosa width of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.
  • Peri-implant mucosa thickness — 1-year follow-up of all implants
    To measure peri-implant mucosa thickness of subgingival and submucosal injection of injectable platelet-rich fibrin in patients with inadequate peri-implant soft tissue phenotype at 1-year follow-up.

Trial sites (1)

FacilityCityRegionStatus
Kütahya Health Sciences University Faculty of Dentistry Kütahya Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06753396 on ClinicalTrials.gov ↗ ← All trials in Turkey