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

NCT07033351 | Completed

• 1 other identifier: MUOSU-202131
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platelet-Rich Fibrin (PRF); Dental Implant; Keratinized Mucosa; Crestal Bone Level; Soft Tissue Healing

Outcome Measures

Primary Outcomes (6)

• Ridge Width Changes (RW)

  The changes in Ridge Width is measured at the reference points using a digital vernier caliper.

  Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks

• Bone Width (BW)

  Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.

  Baseline (preoperative), and 12 weeks postoperatively

• Change in width of keratinized tissue (KTW)

  Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.

  Baseline (preoperative), 6 weeks, and 12 weeks

• Keratinized Tissue Thickness (KTT)

  Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.

  Baseline (preoperative), and 12 weeks postoperatively

• Radiographic Mucosal Thickness (RT)

  Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.

  Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks

• Crestal Bone Height (BH)

  Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.

  Immediate postoperative, 6 weeks, and 12 weeks

Secondary Outcomes (2)

• Plaque Index (PI)

  Baseline (preoperative), 6 weeks, and 12 weeks

• Gingival Index (GI)

  Baseline (preoperative), 6 weeks, and 12 weeks

Study Arms (3)

0 PRF

ACTIVE COMPARATOR

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

Procedure: Dental implant placement without PRF

1 PRF

EXPERIMENTAL

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

Biological: Single-layer PRF membrane application

3 PRF

EXPERIMENTAL

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

Biological: Triple-layer PRF membrane application

Interventions

Dental implant placement without PRF PROCEDURE

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

0 PRF

Single-layer PRF membrane application BIOLOGICAL

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

1 PRF

Triple-layer PRF membrane application BIOLOGICAL

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

3 PRF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

University of Mosul / College of Dentistry

Mosul, Nenavah, 41002, Iraq

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: February 1, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

IR (1)