Ridge PreservationNCT07281053
E-PRF vs Collagen Membranes in Ridge Preservation
A study testing Barrier membrane for ridge preservation in people with Ridge Preservation, run by Center for Advanced Rejuvenation and Esthetics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation
- What is being tested?
- Barrier membrane for ridge preservation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and Female subjects requiring at least one extraction and replacement with a dental implant.
- No contraindications to dental implant placement
Who cannot join
- Smokers
- Autoimmune disease or disorder
- Neurologic disease or disorder
- Major mechanical obstruction to the mouth opening
- Acute capsulitis
- Bone metabolic disease
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ridge Preservation
- Being tested
- Barrier membrane for ridge preservation
- Keywords
- Ridge preservation, extended platelet-rich fibrin, platelet-rich fibrin, Albumin-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrier membrane for ridge preservationProcedure or surgery
Various membranes utilized in ridge preservation were studied
| Study group | Role | What they receive |
|---|---|---|
| Collagen Membrane | Active comparator | Control group, Collagen membrane Receives: Procedure: Barrier membrane for ridge preservation |
| E-PRF membrane fabricated extra-orally | Experimental | E-PRF membrane fabricated extra-orally Receives: Procedure: Barrier membrane for ridge preservation |
| membrane w/solid | Experimental | E-PRF membrane fabricated extra-orally with a solid membrane overtop Receives: Procedure: Barrier membrane for ridge preservation |
| Bio-Filler | Experimental | E-PRF fabricated intra-orally as a Bio-Filler Receives: 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 Receives: Procedure: Barrier membrane for ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: intra-operative time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Feb 2025
- Primary completion1 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Advanced Rejuvenation and Esthetics
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nathan Estrin, Center for Advanced Rejuvenation and Esthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281053
- Sponsor's protocol ID
- 13180-NEstrin
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Extended Platelet-Rich Fibrin Membranes in Comparison to Collagen Membranes for Socket Grafting: Part 2: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07281053
- Acronym / sponsor ID
- 13180-NEstrin
- Conditions
- Ridge Preservation
- Keywords
- Ridge preservation, extended platelet-rich fibrin, platelet-rich fibrin, Albumin-PRF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Center for Advanced Rejuvenation and EstheticsResearch network
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Collagen Membrane | Active comparator | Procedure: Barrier membrane for ridge preservationControl group, Collagen membrane |
| E-PRF membrane fabricated extra-orally | Experimental | Procedure: Barrier membrane for ridge preservationE-PRF membrane fabricated extra-orally |
| membrane w/solid | Experimental | Procedure: Barrier membrane for ridge preservationE-PRF membrane fabricated extra-orally with a solid membrane overtop |
| Bio-Filler | Experimental | Procedure: Barrier membrane for ridge preservationE-PRF fabricated intra-orally as a Bio-Filler |
| Bio-Filler w/solid | Experimental | Procedure: Barrier membrane for ridge preservationE-PRF fabricated intra-orally as a Bio-Filler with a solid-PRF membrane overtop |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male and Female subjects requiring at least one extraction and replacement with a dental implant.
- No contraindications to dental implant placement
Key exclusion criteria (10 listed)
- Smokers
- Autoimmune disease or disorder
- Neurologic disease or disorder
- Major mechanical obstruction to the mouth opening
- Acute capsulitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barrier membrane for ridge preservationVarious membranes utilized in ridge preservation were studied | Procedure or surgery | Bio-Filler, Bio-Filler w/solid, Collagen Membrane, E-PRF membrane fabricated extra-orally, membrane w/solid |
Primary outcome
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.
3 secondary outcomes
Soft tissue thickness measured in mm.
Time frame: 3 months
Clinician reported wound healing outcomes
Time frame: 2 weeks
Time for membrane fabrication measured in seconds
Time frame: intra-operative time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. Data will be shared upon request
Related trials for Ridge Preservation
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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Biotivity A-C Membrane Socket Preservation Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrier membrane for ridge preservation in people with Ridge Preservation, run by Center for Advanced Rejuvenation and Esthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Vertical and Horizontal Dimensions measured in mm (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.