E-PRF vs Collagen Membranes in Ridge Preservation

Use of Extended Platelet-Rich Fibrin Membranes in Comparison to Collagen Membranes for Socket Grafting: Part 2: A Randomized Clinical Trial

Dental implants are often considered the gold standard to replace missing teeth. Having success with dental implants depends on the hard tissue and soft tissue remaining after tooth extractions. The first step to successful dental implant placement begins with proper socket grafting which includes placing a bone graft and membrane among other biomaterials such as platelet-rich fibrin (PRF) to prevent the collapse of the ridge that occurs after a dental extraction.

While platelet-rich fibrin is commonly utilized for ridge preservation, it is often used in conjunction with a collagen membrane due to the fact that it has a short resorption time lasting roughly 2 weeks. However, recently, it was discovered that by heating the plasma layer and denaturing the albumin, the resorption properties of PRF could be extended from 2 weeks to 4-6 months. This extended platelet-rich fibrin (e-PRF) membrane is a promising replacement to collagen membranes in various surgeries. The investigators previously demonstrated that e-PRF is a safe and feasible alternative to conventional membranes with 4 different iterations of applying the novel e-PRF membrane. However, there still lacks a comparative study to traditional collagen membranes and between the 4 different iterations.

Four different techniques utilizing e-PRF membranes for ridge augmentation will be performed with a collagen membrane as a control group. These techniques include 1) e-PRF as a sole barrier membrane, 2) layering a solid-PRF membrane over the e-PRF membrane, 3) fabricating e-PRF intra-orally in gel form as a Bio-Filler, and 4) Fabricating the e-PRF membrane intra-orally under a solid-PRF membrane.

Study Overview

• Status: Completed
• Conditions: Ridge Preservation
• Intervention / Treatment: Procedure: Barrier membrane for ridge preservation

Detailed Description

Dental implants are often considered the gold standard to replace missing teeth. Having success with dental implants depends on the hard tissue and soft tissue remaining after tooth extractions. The first step to successful dental implant placement begins with proper socket grafting which includes placing a bone graft and membrane among other biomaterials such as platelet-rich fibrin (PRF) to prevent the collapse of the ridge that occurs after a dental extraction.

While platelet-rich fibrin is commonly utilized for ridge preservation, it is often used in conjunction with a collagen membrane due to the fact that it has a short resorption time lasting roughly 2 weeks. However, recently, it was discovered that by heating the plasma layer and denaturing the albumin, the resorption properties of PRF could be extended from 2 weeks to 4-6 months. This extended platelet-rich fibrin (e-PRF) membrane is a promising replacement to collagen membranes in various surgeries. Previously, it was demonstrated that it is a safe a feasible alternative to conventional membranes with 4 different iterations of applying the novel e-PRF membrane. However, there still lacks a comparative study to traditional collagen membranes and between the 4 different iterations.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34240
      • Lakewood Ranch Dental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and Female subjects requiring at least one extraction and replacement with a dental implant.
• No contraindications to dental implant placement

Exclusion Criteria:

• Smokers
• Autoimmune disease or disorder
• Neurologic disease or disorder
• Major mechanical obstruction to the mouth opening
• Acute capsulitis
• Bone metabolic disease
• Current systemic antibiotic treatment or within 3 months prior to the study
• Drug addiction or alcohol abuse
• Pregnancy, planning to become pregnant and or nursing
• Type 1 diabetes Uncontrolled Type 2 diabetes (Anyone with an A1c >= 7%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collagen Membrane; Control group, Collagen membrane	Procedure: Barrier membrane for ridge preservation; Various membranes utilized in ridge preservation were studied
Experimental: E-PRF membrane fabricated extra-orally	Procedure: Barrier membrane for ridge preservation; Various membranes utilized in ridge preservation were studied
Experimental: membrane w/solid; E-PRF membrane fabricated extra-orally with a solid membrane overtop	Procedure: Barrier membrane for ridge preservation; Various membranes utilized in ridge preservation were studied
Experimental: Bio-Filler; E-PRF fabricated intra-orally as a Bio-Filler	Procedure: Barrier membrane for ridge preservation; Various membranes utilized in ridge preservation were studied
Experimental: Bio-Filler w/solid; E-PRF fabricated intra-orally as a Bio-Filler with a solid-PRF membrane overtop	Procedure: Barrier membrane for ridge preservation; Various membranes utilized in ridge preservation were studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Vertical and Horizontal Dimensions measured in mm	Cone Beam Computed Tomography (CBCT) scans were acquired for all participants immediately after socket grafting and again at three months post-operatively. Horizontal ridge width was measured on cross-sectional images at three standard-ized apical levels relative to the alveolar crest: 1 mm (RW-1), 3 mm (RW-3), and 5 mm (RW-5). Measurements were conducted perpendicular to a vertical reference line drawn through the midpoint of the grafted socket. Buccal height (BH) and lingual height (LH) were measured at both time points as the linear distance from the most apical portion of the socket to the most coronal portion of the alveolar ridge, parallel to the same vertical reference line. Baseline buccal bone thickness (BBT) was measured on cross-sectional images at 1mm (BBT-1), 3mm (BBT-3), and 5mm (BBT-5) from the crest, parallel to a horizontal reference line.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue thickness measured in mm.	Soft tissue thickness was measured utilizing a standardized mechanical probing procedure with a #40 endodontic reamer equipped with an adjustable rubber stopper. Measurements were taken at the buccal crest, and 5 mm apical to the crest, both pre-operatively and at three months post-operatively, corresponding to the time of im-plant placement. Moreover, mid-occlusal soft tissue thickness (OSTT) was assessed at the three-month follow-up. At each measurement point, the reamer was gently advanced perpendicularly through the mucosa until hard tissue contact was obtained. The distance from the tip of the reamer to the rubber stopper was then calculated utilizing a digital caliper to identify soft tissue thickness. All measurements were carried out by a calibrated investigator under consistent positioning and lighting conditions to minimize variability.	3 months
Clinician reported wound healing outcomes	At the two-week post-operative visit, intraoral photographs of each extraction site were taken using a CANON digital camera. The images were independently assessed by three blinded clinicians utilizing the Landry, Turnbull, and Howley Wound Healing Index (LWHI). Healing was scored on a scale from 1 to 5, where 1 indicated very poor healing and 5 indicated excellent healing.	2 weeks
Time for membrane fabrication measured in seconds	For all patients in the treatment groups, the time to fabricate and apply the e-PRF iteration was recorded. This included the time to draw blood into the collection tubes, centrifugation, using the Bio-Heat to denature albumin, cooling the tubes, mixing the e-PRF with liquid-PRF, allowing the membrane to set, harvesting and flattening the solid-PRF membranes, and intraoral application of the membranes.	intra-operative time.

Collaborators and Investigators

• Sponsor: Center for Advanced Rejuvenation and Esthetics

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: November 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: platelet-rich fibrin; Ridge preservation; extended platelet-rich fibrin; Albumin-PRF
• Other Study ID Numbers: 13180-NEstrin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared upon request
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: Data will be provided to researchers conducting a meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No