Trial Outcomes & Findings for Changes of Soft and Hard Tissues After Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot (NCT NCT03331185)
NCT ID: NCT03331185
Last Updated: 2020-04-30
Results Overview
Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting
Results posted on
2020-04-30
Participant Flow
Participant milestones
| Measure |
Freeze Dried Bone Allograft
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Freeze Dried Bone Allograft
n=14 Participants
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
n=12 Participants
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.43 years
STANDARD_DEVIATION 12.92 • n=14 Participants
|
63.33 years
STANDARD_DEVIATION 14.66 • n=12 Participants
|
62.31 years
STANDARD_DEVIATION 13.5 • n=26 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
3 Participants
n=12 Participants
|
8 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
9 Participants
n=12 Participants
|
18 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
14 participants
n=14 Participants
|
12 participants
n=12 Participants
|
26 participants
n=26 Participants
|
|
Buccolingual Ridge Width measured 1mm from crest
|
11.38 Millimeters
STANDARD_DEVIATION 2.4 • n=14 Participants
|
11.28 Millimeters
STANDARD_DEVIATION 1.41 • n=12 Participants
|
11.3 Millimeters
STANDARD_DEVIATION 1.8 • n=26 Participants
|
|
Buccolingual Ridge Width measured 3mm from crest
|
11.82 Millimeters
STANDARD_DEVIATION 2.37 • n=14 Participants
|
12.20 Millimeters
STANDARD_DEVIATION 1.53 • n=12 Participants
|
12 Millimeters
STANDARD_DEVIATION 1.9 • n=26 Participants
|
|
Buccolingual Ridge Width measured 5mm from crest
|
12.17 Millimeters
STANDARD_DEVIATION 2.49 • n=14 Participants
|
12.47 Millimeters
STANDARD_DEVIATION 1.94 • n=12 Participants
|
12.3 Millimeters
STANDARD_DEVIATION 2.2 • n=26 Participants
|
|
Thickness of buccal plate measured at 1mm from crest
|
0.98 Millimeters
STANDARD_DEVIATION 0.5 • n=14 Participants
|
0.89 Millimeters
STANDARD_DEVIATION 0.3 • n=12 Participants
|
0.93 Millimeters
STANDARD_DEVIATION 0.4 • n=26 Participants
|
|
Thickness of buccal plate measured at 3mm from crest
|
1.08 Millimeters
STANDARD_DEVIATION 0.8 • n=14 Participants
|
1.31 Millimeters
STANDARD_DEVIATION 0.58 • n=12 Participants
|
1.19 Millimeters
STANDARD_DEVIATION 0.69 • n=26 Participants
|
|
Thickness of buccal plate measured at 5mm from crest
|
1.26 Millimeters
STANDARD_DEVIATION 0.98 • n=14 Participants
|
1.50 Millimeters
STANDARD_DEVIATION 0.64 • n=12 Participants
|
1.38 Millimeters
STANDARD_DEVIATION 0.8 • n=26 Participants
|
|
Buccolingual Keratinised Tissue Width
|
15.25 Millimeters
STANDARD_DEVIATION 5.32 • n=14 Participants
|
16.4 Millimeters
STANDARD_DEVIATION 4.39 • n=12 Participants
|
15.8 Millimeters
STANDARD_DEVIATION 4.8 • n=26 Participants
|
PRIMARY outcome
Timeframe: Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and graftingCalculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.
Outcome measures
| Measure |
Freeze Dried Bone Allograft
n=14 Participants
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
n=12 Participants
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
|---|---|---|
|
Overall Horizontal Change in Alveolar Ridge Width
|
-1.34 Millimeters
Standard Error 0.38
|
-2.21 Millimeters
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and graftingPopulation: Only nine patients had implants placed within the exact specified 12 week timeframe from the date of extraction, therefore data collection and analysis were only performed on these participants.
Difference in post operative measurement analysis of keratinized gingiva changes following extraction and alveolar ridge preservation
Outcome measures
| Measure |
Freeze Dried Bone Allograft
n=4 Participants
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
n=5 Participants
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
|---|---|---|
|
Buccolingual Change in Width of Keratinized Soft Tissue
|
-1 Millimeters
Standard Error 3.03
|
-4 Millimeters
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Measured at 7 days following extraction and graftingPost-operative pain and complications measured by VAS-questionnaire obtained following extraction and grafting. The VAS-questionnaire contained the following categories to be answered 7days post-operatively: Pain, Swelling. A visual line scale of 100mm in length was provided with no pain/swelling on the one end and severe pain/swelling on the opposite end. Participants were instructed to rate their pain and swelling by marking a single line on the scale indicating the degree of pain/swelling they experienced. Markings were physically measured on the scale and converted into a score with 0 representing no pain/swelling and 1 representing severe pain/swelling.
Outcome measures
| Measure |
Freeze Dried Bone Allograft
n=14 Participants
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
n=12 Participants
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
|---|---|---|
|
Post-operative Pain and Swelling
|
0.22 score on a scale
Standard Deviation 0.29
|
0.23 score on a scale
Standard Deviation 0.30
|
Adverse Events
Freeze Dried Bone Allograft
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
L-PRF Clot
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Freeze Dried Bone Allograft
n=14 participants at risk
Socket filled with Mineralized Cortical Freeze Dried Bone Allograft
Freeze Dried Bone Allograft: Human derived bone particles used in oral and periodontal grafting procedures
|
L-PRF Clot
n=12 participants at risk
Socket filled with L-PRF Clot
L-PRF clot: L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
|
|---|---|---|
|
Surgical and medical procedures
Membrane loss earlier than 4weeks
|
50.0%
7/14 • 12weeks
Patients were monitored 1-2weekly during the 12week healing period and any adverse events recorded by the treating clinician.
|
25.0%
3/12 • 12weeks
Patients were monitored 1-2weekly during the 12week healing period and any adverse events recorded by the treating clinician.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place