Trial Outcomes & Findings for A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw (NCT NCT02255149)
NCT ID: NCT02255149
Last Updated: 2023-11-21
Results Overview
Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
5 months
Results posted on
2023-11-21
Participant Flow
Participant milestones
| Measure |
Bone/Mesh
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Bone/Mesh
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Withdrawal by PI
|
1
|
|
Overall Study
Implant Failure
|
1
|
Baseline Characteristics
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
Baseline characteristics by cohort
| Measure |
Bone/Mesh
n=10 Participants
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
|
|---|---|
|
Age, Customized
>=18
|
9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Bone height
|
9.8 millimeters
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsDiameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
Outcome measures
| Measure |
Bone/Mesh
n=5 Participants
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
|
|---|---|
|
Bone Height
|
12.2 millimeters
Interval 8.0 to 14.4
|
Adverse Events
Bone/Mesh
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bone/Mesh
n=10 participants at risk
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
|
|---|---|
|
Surgical and medical procedures
Implant Failure
|
20.0%
2/10 • Number of events 3 • 2 years 6 months
|
|
Surgical and medical procedures
Mesh Exposure/Removal
|
60.0%
6/10 • Number of events 6 • 2 years 6 months
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
|
Blood and lymphatic system disorders
Hypoxic Tissue
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
|
Surgical and medical procedures
Lack of Bone Growth
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
|
Surgical and medical procedures
Wound Opening at Mesh site
|
20.0%
2/10 • Number of events 2 • 2 years 6 months
|
|
Surgical and medical procedures
Soft Tissue Dehiscence
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
|
General disorders
Soreness on Tongue
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
|
General disorders
Throbbing Pain
|
10.0%
1/10 • Number of events 1 • 2 years 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place