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This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant placement.
Pre (baseline)- and post-grafting (3 months) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the dimensional ridge changes between sites grafted with L-PRF/FDBA layered technique vs. L-PRF/FDBA and L-PRF alone.
Histological analysis will be performed by a bone biopsy taken at time of surgical re-entry (after 3 months) of grafted sites to place the dental implant and assessed for differences in new bone formation between the three types of graft.
This study is a prospective, three-arm randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets using either L-PRF/FDBA layered technique or L-PRF/FDBA or L-PRF alone in a total of 30 patients (10 in each arm).
Qualifying participants and defects will be randomized following a computerized permutation block to receive either technique on day of surgery. Tooth extraction will be performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft.
The mineralized cortico-cancellous bone allograft that will be used in this study will be obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.
Bone core biopsies will be harvested at time of implant placement 3 months following socket grafting. Bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between three treatment groups.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
Cone beam computed tomography (CBCT) initial scans are conducted immediately following socket grafting and second scans obtained prior to implant placement. Virtual implant planning software will be utilized to assess and compare the 2- and 3-dimensional changes for all defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridge preservation using L-PRF/ FDBA Layered | Experimental | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique |
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| Ridge preservation using L-PRF/ FDBA | Experimental | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA |
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| Ridge preservation using L-PRF | Experimental | Atraumatic tooth extraction following by socket grafting using L-PRF alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridge preservation using L-PRF/FDBA layered technique | Procedure | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Clinical Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique | Compare quantitative clinical alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups. Clinically we will measure the bone width of the ridge at time of extraction and after three months during the implant placement procedure. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement. | From baseline to 3 months |
| Measurements of the Radiographic Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique | Compare quantitative radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan. The bone width at the extraction site will be measured on the CBCT taken directly after the extraction. The same measurement will be taken at the 3 month follow up CBCT. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement. | From baseline to 3 months |
| Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | Measure quantitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone at the healed socket site. The quality of the bone created will analyzed using a descriptive analysis. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ridge Preservation Using L-PRF/ FDBA Layered | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique Ridge preservation using L-PRF/FDBA layered technique: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2023 |
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| Ridge preservation using L-PRF/FDBA | Procedure | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA |
|
| Ridge preservation using L-PRF | Procedure | Atraumatic tooth extraction following by socket grafting using L-PRF |
|
| Ridge Preservation Using L-PRF/ FDBA |
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA Ridge preservation using L-PRF/FDBA: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA |
| FG002 | Ridge Preservation Using L-PRF | Atraumatic tooth extraction following by socket grafting using L-PRF alone Ridge preservation using L-PRF: Atraumatic tooth extraction following by socket grafting using L-PRF |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ridge Preservation Using L-PRF/ FDBA Layered | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique Ridge preservation using L-PRF/FDBA layered technique: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique |
| BG001 | Ridge Preservation Using L-PRF/ FDBA | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA Ridge preservation using L-PRF/FDBA: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA |
| BG002 | Ridge Preservation Using L-PRF | Atraumatic tooth extraction following by socket grafting using L-PRF alone Ridge preservation using L-PRF: Atraumatic tooth extraction following by socket grafting using L-PRF |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measurements of Clinical Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique | Compare quantitative clinical alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups. Clinically we will measure the bone width of the ridge at time of extraction and after three months during the implant placement procedure. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement. | Posted | Mean | Standard Deviation | mm | From baseline to 3 months |
|
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| Primary | Measurements of the Radiographic Dimensional Changes at Alveolar Ridge 3 Months After Ridge Preservation Procedure Using L-PRF Alone, L-PRF/FDBA, and L-PRF/FDBA Layered Technique | Compare quantitative radiographic alveolar ridge dimensions (in mm) 3 months after ridge preservation between the three groups using a CBCT scan. The bone width at the extraction site will be measured on the CBCT taken directly after the extraction. The same measurement will be taken at the 3 month follow up CBCT. The dimensional changes will be calculated by subtracting the follow measurement from the initial measurement. | Posted | Mean | Standard Deviation | mm | From baseline to 3 months |
| ||||||||||||||||||||||||||||||||||
| Primary | Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | Measure quantitative histologic characteristics of new bone between the three groups after 3 months of ridge preservation by quantifying the distribution (in %) of new vital bone at the healed socket site. The quality of the bone created will analyzed using a descriptive analysis. | From the twenty-three(23) patients, histomorphometric analysis was performed on fifteen bone core biopsies obtained from the healed sockets (five in each group). | Posted | Mean | Standard Deviation | in % | 3 months |
|
Baseline to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ridge Preservation Using L-PRF/ FDBA Layered | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique Ridge preservation using L-PRF/FDBA layered technique: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Ridge Preservation Using L-PRF/ FDBA | Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA Ridge preservation using L-PRF/FDBA: Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Ridge Preservation Using L-PRF | Atraumatic tooth extraction following by socket grafting using L-PRF alone Ridge preservation using L-PRF: Atraumatic tooth extraction following by socket grafting using L-PRF | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolaas C. Geurs, DDS, MS, Interim Dean, Principal Investigator | University of Alabama at Birmingham | 205-9344506 | ngeurs@uab.edu |
| Dec 6, 2023 |
| Prot_SAP_000.pdf |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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