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E-PRF vs Collagen Membranes in Ridge Preservation

C

Center for Advanced Rejuvenation and Esthetics

Status

Completed

Conditions

Ridge Preservation

Treatments

Procedure: Barrier membrane for ridge preservation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT07281053
13180-NEstrin

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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%)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

55 participants in 5 patient groups

Collagen Membrane
Active Comparator group
Description:
Control group, Collagen membrane
Treatment:
Procedure: Barrier membrane for ridge preservation
E-PRF membrane fabricated extra-orally
Experimental group
Description:
E-PRF membrane fabricated extra-orally
Treatment:
Procedure: Barrier membrane for ridge preservation
membrane w/solid
Experimental group
Description:
E-PRF membrane fabricated extra-orally with a solid membrane overtop
Treatment:
Procedure: Barrier membrane for ridge preservation
Bio-Filler
Experimental group
Description:
E-PRF fabricated intra-orally as a Bio-Filler
Treatment:
Procedure: Barrier membrane for ridge preservation
Bio-Filler w/solid
Experimental group
Description:
E-PRF fabricated intra-orally as a Bio-Filler with a solid-PRF membrane overtop
Treatment:
Procedure: Barrier membrane for ridge preservation

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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