Trial Outcomes & Findings for Effect of Healing Time on New Bone Formation Following Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft (NCT NCT02154386)
NCT ID: NCT02154386
Last Updated: 2015-12-03
Results Overview
Bone core biopsy will be evaluated histologically for percent new vital bone formation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting
Results posted on
2015-12-03
Participant Flow
Participant milestones
| Measure |
8-10 Week Healing Group
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Healing Time on New Bone Formation Following Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft
Baseline characteristics by cohort
| Measure |
8-10 Week Healing Group
n=23 Participants
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
n=23 Participants
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
n=93 Participants
|
55.4 years
n=4 Participants
|
55.7 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and graftingBone core biopsy will be evaluated histologically for percent new vital bone formation
Outcome measures
| Measure |
8-10 Week Healing Group
n=20 Participants
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
n=19 Participants
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
|---|---|---|
|
Percent New Vital Bone Formation
|
32.63 percentage of vital bone
Standard Deviation 21.45
|
47.41 percentage of vital bone
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and graftingRidge width measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge width are determined (negative number signifies loss of ridge width)
Outcome measures
| Measure |
8-10 Week Healing Group
n=22 Participants
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
n=19 Participants
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
|---|---|---|
|
Change in Ridge Width
|
-1.41 ridge width change (mm)
Standard Deviation 2.11
|
-0.66 ridge width change (mm)
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and graftingRidge height measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge height are determined (negative number signifies loss of ridge height)
Outcome measures
| Measure |
8-10 Week Healing Group
n=22 Participants
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
n=19 Participants
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
|---|---|---|
|
Change in Buccal Ridge Height
|
-1.82 change in bone height (mm)
Standard Deviation 2.23
|
-1.18 change in bone height (mm)
Standard Deviation 1.31
|
Adverse Events
8-10 Week Healing Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
18-20 Week Healing Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
8-10 Week Healing Group
n=22 participants at risk
dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
18-20 Week Healing Group
n=21 participants at risk
dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting
Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA
|
|---|---|---|
|
Surgical and medical procedures
poor healing of extraction site
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
Additional Information
Dr. Brian Mealey
UT Health Science Center San Antonio (School of Dentistry)
Phone: 210-567-3567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place