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

NCT07033351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-06-06
Completion
2025-06-06

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033351 on ClinicalTrials.gov