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Completed

NCT Number: NCT07281053

E-PRF vs Collagen Membranes in Ridge Preservation

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.

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Key information

Conditions

Ridge Preservation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakewood Ranch Dental

Sarasota, Florida, 34240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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%)

Treatment and study plan

Barrier membrane for ridge preservation

Procedure

Various membranes utilized in ridge preservation were studied

Primary outcomes

  1. Radiographic Vertical and Horizontal Dimensions measured in mm

    Time frame: 3 months

    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.

Secondary outcomes

  1. Soft tissue thickness measured in mm.

    Time frame: 3 months

    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.

  2. Clinician reported wound healing outcomes

    Time frame: 2 weeks

    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.

  3. Time for membrane fabrication measured in seconds

    Time frame: intra-operative time.

    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.

Sponsors and collaborators

Lead sponsor

Center for Advanced Rejuvenation and Esthetics

Network

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2025
Registry last updated
Dec 15, 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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