Trial Outcomes & Findings for Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft (NCT NCT05400213)
NCT ID: NCT05400213
Last Updated: 2025-06-19
Results Overview
Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Wound healing time ( approximately 18 to 20 weeks)
Results posted on
2025-06-19
Participant Flow
All patients presented with one non-molar tooth that was indicated for extraction and planned for an implant restoration. Additional inclusion criteria included the following: 1) adequate restorative space for an implant restoration, 2) at least 10mm of alveolar ridge height before any vital structures, and 3) non-smokers or current smokers smoking \<10 cigarettes per day.
Participant milestones
| Measure |
Group 1 Vallos (DCP)
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallomix (DPX)
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 3 Vallos-F (DCF)
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 4 Vallomix-F (DFX)
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
24
|
27
|
|
Overall Study
Completed Histologic Analysis
|
23
|
27
|
24
|
27
|
|
Overall Study
Completed Clinical Measurements
|
24
|
26
|
23
|
26
|
|
Overall Study
COMPLETED
|
23
|
26
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallomix (DPX)
n=27 Participants
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 3 Vallos-F (DCF)
n=24 Participants
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 4 Vallomix-F (DFX)
n=27 Participants
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
15 Participants
n=24 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=24 Participants
|
10 Participants
n=27 Participants
|
43 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=24 Participants
|
18 Participants
n=27 Participants
|
15 Participants
n=24 Participants
|
17 Participants
n=27 Participants
|
59 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
27 participants
n=27 Participants
|
24 participants
n=24 Participants
|
27 participants
n=27 Participants
|
102 participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 16.9 • n=24 Participants
|
58.6 years
STANDARD_DEVIATION 16.8 • n=27 Participants
|
55.9 years
STANDARD_DEVIATION 15.4 • n=24 Participants
|
63.2 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
60.17 years
STANDARD_DEVIATION 14.98 • n=102 Participants
|
PRIMARY outcome
Timeframe: Wound healing time ( approximately 18 to 20 weeks)Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Percentage Vital Bone Formation
|
37.33 percentage of vital bone formation
Standard Deviation 14.31
|
40.76 percentage of vital bone formation
Standard Deviation 13.94
|
24.46 percentage of vital bone formation
Standard Deviation 13.75
|
23.85 percentage of vital bone formation
Standard Deviation 17.71
|
SECONDARY outcome
Timeframe: Wound healing time ( approximately 18 to 20 weeks)Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery.
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Percentage of Residual Graft Material
|
16.25 percentage of residual graft material
Standard Deviation 13.84
|
3.57 percentage of residual graft material
Standard Deviation 2.78
|
23.39 percentage of residual graft material
Standard Deviation 8.95
|
18.42 percentage of residual graft material
Standard Deviation 10.24
|
SECONDARY outcome
Timeframe: Baseline to 18-20 weeksMeasure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery.
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Percentage of Connective Tissue at Time of Implant
|
46.41 percentage of connective tissue
Standard Deviation 14.23
|
55.67 percentage of connective tissue
Standard Deviation 14.28
|
52.03 percentage of connective tissue
Standard Deviation 12.10
|
57.73 percentage of connective tissue
Standard Deviation 14.72
|
SECONDARY outcome
Timeframe: Baseline to 18-20 weeksMeasure of change in ridge width from extraction to healing time
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Change in Ridge Width (Clinical Measurement)
|
-1.19 mm
Standard Deviation 0.94
|
-1.02 mm
Standard Deviation 1.57
|
-1.15 mm
Standard Deviation 1.02
|
-1.00 mm
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Baseline to 18-20 weeksMeasure of change in buccal ridge height from extraction to healing time
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Change in Buccal Ridge Height (Clinical Measurement)
|
-1.67 mm
Standard Deviation 1.99
|
-0.85 mm
Standard Deviation 1.33
|
-0.41 mm
Standard Deviation 2.19
|
-1.08 mm
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline to 18-20 weeksMeasure of change in lingual ridge height from extraction to healing time
Outcome measures
| Measure |
Group 1 Vallos (DCP)
n=24 Participants
Subjects will be randomized into this group and receive Vallos (DCP): Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F (DPX)
n=27 Participants
Subjects will be randomized into this group and receive Vallos-F (DPX): Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix (DCF)
n=24 Participants
Subjects will be randomized into this group and receive Vallomix (DCF): A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 Participants
Subjects will be randomized into this group and receive Vallomix-F (DFX): A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Change in Lingual Ridge Height (Clinical Measurement)
|
-1.85 mm
Standard Deviation 1.63
|
-0.75 mm
Standard Deviation 1.76
|
-1.17 mm
Standard Deviation 1.72
|
-1.75 mm
Standard Deviation 1.80
|
Adverse Events
Group 1 Vallos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Vallos-F
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 Vallomix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 Vallomix-F
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 Vallos
n=24 participants at risk
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form
|
Group 2 Vallos-F
n=27 participants at risk
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
|
Group 3 Vallomix
n=24 participants at risk
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate
|
Group 4 Vallomix-F
n=27 participants at risk
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/24 • Baseline to 18-20 weeks
|
3.7%
1/27 • Number of events 1 • Baseline to 18-20 weeks
|
0.00%
0/24 • Baseline to 18-20 weeks
|
0.00%
0/27 • Baseline to 18-20 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Brian Mealeey, DDS, MS
University of Texas Health Science Center at San Antonio
Phone: 210-450-8736
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place