NCT07033351

The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period. Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all? To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts. Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.

Conditions

• Dental Implant
• Platelet Rich Fibrin
• Keratinized Mucosa
• Crestal Bone Loss

Interventions

Type	Name	Description
PROCEDURE	Dental implant placement without PRF	Standard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site.
BIOLOGICAL	Single-layer PRF membrane application	PRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure.
BIOLOGICAL	Triple-layer PRF membrane application	Three autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-06-06
• Completion: 2025-06-06
• First posted: 2025-06-24
• Last updated: 2025-06-27

Locations

1 site across 1 country: Iraq