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Completed

NCT Number: NCT07033351

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

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.

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Key information

Conditions

Dental Implant Crestal Bone Loss Keratinized Mucosa Platelet Rich Fibrin

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mosul / College of Dentistry

Mosul, Nenavah, 41002, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Ridge Width Changes (RW)

    Time frame: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks

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

  2. Bone Width (BW)

    Time frame: Baseline (preoperative), and 12 weeks postoperatively

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

  3. Change in width of keratinized tissue (KTW)

    Time frame: Baseline (preoperative), 6 weeks, and 12 weeks

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

  4. Keratinized Tissue Thickness (KTT)

    Time frame: Baseline (preoperative), and 12 weeks postoperatively

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

  5. Radiographic Mucosal Thickness (RT)

    Time frame: Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks

    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.

  6. Crestal Bone Height (BH)

    Time frame: Immediate postoperative, 6 weeks, and 12 weeks

    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.

Secondary outcomes

  1. Plaque Index (PI)

    Time frame: Baseline (preoperative), 6 weeks, and 12 weeks

    O'Leary plaque index

  2. Gingival Index (GI)

    Time frame: Baseline (preoperative), 6 weeks, and 12 weeks

    Gingival Bleeding Index

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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