Ridge Preservation
Conditions
Keywords
L-PRF, Bone Allograft, Ridge Preservation, Socket grafting, Bone regeneration
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERidge preservation using L-PRF/FDBA layered technique
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
PROCEDURERidge preservation using L-PRF/FDBA
Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
PROCEDURERidge preservation using L-PRF
Atraumatic tooth extraction following by socket grafting using L-PRF
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking and able to read and understand English informed consent document * At least 18 years old. * Must be a patient at the UAB School of Dentistry * Patient is willing and able to comply with all steps of the study * Hopeless single-rooted tooth planned to be replaced with a dental implant and with healthy adjacent teeth not planned for extraction.
Exclusion criteria
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing * Pregnant women * Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From baseline to 3 months | 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. |
| 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 | From baseline to 3 months | 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. |
| Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 9 |
| 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 | 6 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Ridge Preservation Using L-PRF/ FDBA Layered | Ridge Preservation Using L-PRF/ FDBA | Ridge Preservation Using L-PRF | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 6 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 4 Participants | 21 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 | 0 / 6 |
| other Total, other adverse events | 0 / 8 | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 6 |
Outcome results
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.
Time frame: 3 months
Population: From the twenty-three(23) patients, histomorphometric analysis was performed on fifteen bone core biopsies obtained from the healed sockets (five in each group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ridge Preservation Using L-PRF/ FDBA Layered | Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | 52.15 in % | Standard Deviation 9.63 |
| Ridge Preservation Using L-PRF/ FDBA | Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | 58.26 in % | Standard Deviation 2.84 |
| Ridge Preservation Using L-PRF | Assessments of the Histology of the Bone Harvested at the 3 Month Visit. | 38.59 in % | Standard Deviation 10.12 |
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.
Time frame: From baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ridge Preservation Using L-PRF/ FDBA Layered | 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 | 0.88 mm | Standard Deviation 1.55 |
| Ridge Preservation Using L-PRF/ FDBA | 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 | 0.78 mm | Standard Deviation 3.8 |
| Ridge Preservation Using L-PRF | 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 | 0.83 mm | Standard Deviation 2.8 |
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.
Time frame: From baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ridge Preservation Using L-PRF/ FDBA Layered | 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 | 1.03 mm | Standard Deviation 0.91 |
| Ridge Preservation Using L-PRF/ FDBA | 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 | 0.48 mm | Standard Deviation 1.93 |
| Ridge Preservation Using L-PRF | 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 | 0.9 mm | Standard Deviation 0.9 |