Trial Outcomes & Findings for A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts (NCT NCT01572298)
NCT ID: NCT01572298
Last Updated: 2018-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
5 months after surgery
Results posted on
2018-01-02
Participant Flow
Participant milestones
| Measure |
Allograft Alone
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
Allograft Combined With Autograft
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts
Baseline characteristics by cohort
| Measure |
Allograft Alone
n=14 Participants
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
Allograft Combined With Autograft
n=13 Participants
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
47.5 years
STANDARD_DEVIATION 14.5 • n=107 Participants
|
48.9 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 months after surgeryOutcome measures
| Measure |
Allograft Alone
n=12 Participants
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
Allograft Combined With Autograft
n=11 Participants
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
|
|---|---|---|
|
Gain in Horizontal Ridge Dimension
|
3.33 gain in ridge width (mm)
Standard Deviation 0.83
|
3.09 gain in ridge width (mm)
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 5 months after surgeryPopulation: No data were collected for this outcome
Outcome measures
Outcome data not reported
Adverse Events
Allograft Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Allograft Combined With Autograft
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place