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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Membrane | Active Comparator | Control group, Collagen membrane |
|
| E-PRF membrane fabricated extra-orally | Experimental | E-PRF membrane fabricated extra-orally |
|
| membrane w/solid | Experimental | E-PRF membrane fabricated extra-orally with a solid membrane overtop |
|
| Bio-Filler | Experimental | E-PRF fabricated intra-orally as a Bio-Filler |
|
| Bio-Filler w/solid | Experimental | E-PRF fabricated intra-orally as a Bio-Filler with a solid-PRF membrane overtop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barrier membrane for ridge preservation | Procedure | Various membranes utilized in ridge preservation were studied |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakewood Ranch Dental | Sarasota | Florida | 34240 | United States |
Data will be shared upon request
Beginning 3 months and ending 3 years after the publication of results
Data will be provided to researchers conducting a meta-analysis.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2025 | Dec 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2025 | Dec 8, 2025 | SAP_001.pdf |
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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.
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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
| 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. |