Trial Outcomes & Findings for To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets (NCT NCT04133363)
NCT ID: NCT04133363
Last Updated: 2024-09-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
From baseline to 3 months
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
Baseline Characteristics
To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets
Baseline characteristics by cohort
| Measure |
Ridge Preservation Using L-PRF/ FDBA Layered
n=8 Participants
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
|
Ridge Preservation Using L-PRF/ FDBA
n=9 Participants
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
|
Ridge Preservation Using L-PRF
n=6 Participants
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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 3 monthsCompare 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.
Outcome measures
| Measure |
Ridge Preservation Using L-PRF/ FDBA Layered
n=8 Participants
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
|
Ridge Preservation Using L-PRF/ FDBA
n=9 Participants
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
|
Ridge Preservation Using L-PRF
n=6 Participants
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
|
|---|---|---|---|
|
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
|
0.78 mm
Standard Deviation 3.8
|
0.83 mm
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: From baseline to 3 monthsCompare 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.
Outcome measures
| Measure |
Ridge Preservation Using L-PRF/ FDBA Layered
n=8 Participants
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
|
Ridge Preservation Using L-PRF/ FDBA
n=9 Participants
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
|
Ridge Preservation Using L-PRF
n=6 Participants
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
|
|---|---|---|---|
|
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
|
0.48 mm
Standard Deviation 1.93
|
0.9 mm
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: From the twenty-three(23) patients, histomorphometric analysis was performed on fifteen bone core biopsies obtained from the healed sockets (five in each group).
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.
Outcome measures
| Measure |
Ridge Preservation Using L-PRF/ FDBA Layered
n=5 Participants
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
|
Ridge Preservation Using L-PRF/ FDBA
n=5 Participants
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
|
Ridge Preservation Using L-PRF
n=5 Participants
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
|
|---|---|---|---|
|
Assessments of the Histology of the Bone Harvested at the 3 Month Visit.
|
52.15 in %
Standard Deviation 9.63
|
58.26 in %
Standard Deviation 2.84
|
38.59 in %
Standard Deviation 10.12
|
Adverse Events
Ridge Preservation Using L-PRF/ FDBA Layered
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ridge Preservation Using L-PRF/ FDBA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ridge Preservation Using L-PRF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nicolaas C. Geurs, DDS, MS, Interim Dean, Principal Investigator
University of Alabama at Birmingham
Phone: 205-9344506
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place