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

NCT ID: NCT07033351

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-06-06

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Implant Platelet Rich Fibrin Keratinized Mucosa Crestal Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.

Study Groups

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0 PRF

Each implant placed in this group did NOT have PRF membrane placed over the implant.

Group Type ACTIVE_COMPARATOR

Dental implant placement without PRF

Intervention Type PROCEDURE

Standard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site.

1 PRF

Each implant placed in this group had ONE PRF membrane placed over the implant.

Group Type EXPERIMENTAL

Single-layer PRF membrane application

Intervention Type BIOLOGICAL

PRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure.

3 PRF

Each implant placed in this group had THTEE STACKED PRF membranes placed over the implant.

Group Type EXPERIMENTAL

Triple-layer PRF membrane application

Intervention Type BIOLOGICAL

Three autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults (male or female) over 18 years of age.
* Partially edentulous spaces.
* No history of bone augmentation procedures in the implant site.
* Good oral health, as measured by:
* Calibrated gingival bleeding index (≤10%)
* O'Leary plaque index (\<10%)

Exclusion Criteria

* Bleeding disorders.
* Compromised immune systems.
* Excessive smoking or alcohol consumption.
* Poor oral hygiene.
* Diabetes.
* Inability to attend follow-up visits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Mustansiriyah University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahir Tawfeeq Karakchi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Mosul / College of Dentistry

Mosul, Nenavah, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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MUOSU-202131

Identifier Type: -

Identifier Source: org_study_id

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