Trial Outcomes & Findings for An Assessment of Bone Augmentation in Post-Extraction Sockets (NCT NCT00641316)
NCT ID: NCT00641316
Last Updated: 2024-07-19
Results Overview
New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
2 months
Results posted on
2024-07-19
Participant Flow
Randomization was performed by site (teeth) in the mouth. Each participant has only one tooth enrolled in the study.
Unit of analysis: teeth
Participant milestones
| Measure |
1 Atraumatic Teeth Extraction
Teeth extraction followed by natural healing
AtraumaticTeeth Extraction: Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
|
2- FDBA/TCP
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
3 FDBA/TCP+PRP
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
4 FDBA/TCP + PDGF
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9 9
|
11 11
|
12 12
|
9 9
|
|
Overall Study
COMPLETED
|
9 9
|
11 11
|
12 12
|
9 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Assessment of Bone Augmentation in Post-Extraction Sockets
Baseline characteristics by cohort
| Measure |
1 Atraumatic Teeth Extraction
n=9 Participants
Teeth extraction followed by natural healing
AtraumaticTeeth Extraction: Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
|
2- FDBA/TCP
n=11 Participants
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
3 FDBA/TCP+PRP
n=12 Participants
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
4 FDBA/TCP + PDGF
n=9 Participants
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
|
Total
n=41 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Each participant has only one tooth enrolled.
New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.
Outcome measures
| Measure |
1 Atraumatic Teeth Extraction
n=9 teeth
Teeth extraction followed by natural healing
AtraumaticTeeth Extraction: Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
|
2- FDBA/TCP
n=11 teeth
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
3 FDBA/TCP+PRP
n=12 teeth
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites
|
4 FDBA/TCP + PDGF
n=9 teeth
Atraumatic Teeth Extraction/Grafted Extraction Sockets: Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites
|
|---|---|---|---|---|
|
Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets
|
0.43 mm
Standard Deviation 0.24
|
0.27 mm
Standard Deviation 0.07
|
0.36 mm
Standard Deviation 0.15
|
0.28 mm
Standard Deviation 0.09
|
Adverse Events
1 Atraumatic Teeth Extraction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2- FDBA/TCP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 FDBA/TCP+PRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 FDBA/TCP + PDGF
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 Geurs, DDS,MS
University of Alabama at Birmingham
Phone: 2059344506
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place