E-PRF vs Collagen Membranes in Ridge Preservation

NCT07281053 | Completed

• 1 other identifier: 13180-NEstrin
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ridge Preservation

Keywords

Ridge preservation; extended platelet-rich fibrin; platelet-rich fibrin; Albumin-PRF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Soft tissue thickness measured in mm.

  3 months

• Clinician reported wound healing outcomes

  2 weeks

• Time for membrane fabrication measured in seconds

  intra-operative time.

Study Arms (5)

Collagen Membrane

ACTIVE COMPARATOR

Control group, Collagen membrane

Procedure: Barrier membrane for ridge preservation

E-PRF membrane fabricated extra-orally

EXPERIMENTAL

E-PRF membrane fabricated extra-orally

Procedure: Barrier membrane for ridge preservation

membrane w/solid

EXPERIMENTAL

E-PRF membrane fabricated extra-orally with a solid membrane overtop

Procedure: Barrier membrane for ridge preservation

Bio-Filler

EXPERIMENTAL

E-PRF fabricated intra-orally as a Bio-Filler

Procedure: Barrier membrane for ridge preservation

Bio-Filler w/solid

EXPERIMENTAL

E-PRF fabricated intra-orally as a Bio-Filler with a solid-PRF membrane overtop

Procedure: Barrier membrane for ridge preservation

Interventions

Barrier membrane for ridge preservation PROCEDURE

Various membranes utilized in ridge preservation were studied

Bio-Filler; Bio-Filler w/solid; Collagen Membrane; E-PRF membrane fabricated extra-orally; membrane w/solid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Center for Advanced Rejuvenation and Esthetics: lead

Study Sites (1)

Lakewood Ranch Dental

Sarasota, Florida, 34240, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants do not know which treatment they are receiving, Radiologist does not know which group recieved which treatment, and 3 blinded-clinicians will give wound healing scores according to Landy index
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist

Model Details: This research will be a 6-month randomized and controlled trial involving patients requiring at least one extraction and replacement with a dental implant. Participants will be recruited and randomly allocated to receive either one of the four iterations of using e-PRF membranes or a standard resorbable collagen membrane. All patients will be treated surgically with ridge preservation and dental implant placement using standard bone graft material and one of the membranes determined by their assigned group. Primary outcome includes radiographic ridge dimensions, soft tissue thickness, and wound healing outcomes.

Study Record Dates

• First Submitted: November 8, 2025
• First Posted: December 15, 2025
• Study Start: February 20, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 6, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Data will be provided to researchers conducting a meta-analysis.

Locations

US (1)