Trial Outcomes & Findings for Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques (NCT NCT02703480)
NCT ID: NCT02703480
Last Updated: 2024-09-04
Results Overview
intrasurgical clinical measurement in millimeter
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
from 6 months to 8 months following the procedure
Results posted on
2024-09-04
Participant Flow
A total of 11 participants were enrolled for a split-mouth study. 10 participants completed the study (20 sites).
Unit of analysis: Sites
Participant milestones
| Measure |
All Study Participants - d-PTFE
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane
|
All Study Participants - Ti-mesh
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh: Titanium mesh
|
|---|---|---|
|
Overall Study
STARTED
|
11 11
|
11 11
|
|
Overall Study
COMPLETED
|
10 10
|
10 10
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh: Titanium mesh
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 10.058 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Vertical defect height (mm) at measured at baseline
|
4.4 millimeter
STANDARD_DEVIATION 1.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: from 6 months to 8 months following the procedureintrasurgical clinical measurement in millimeter
Outcome measures
| Measure |
All Study Participants - d-PTFE
n=10 Participants
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane
|
All Study Participants - Ti-mesh
n=10 Participants
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh: Titanium mesh
|
|---|---|---|
|
Changes in Vertical Bone Height
|
3.7 millimeter
Standard Deviation 1.2
|
3.2 millimeter
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to 6 months to 8 months following the procedurecompare the rate of post-operative complications over the six months healing period after vertical augmentation procedures
Outcome measures
| Measure |
All Study Participants - d-PTFE
n=10 Participants
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane
|
All Study Participants - Ti-mesh
n=10 Participants
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh: Titanium mesh
|
|---|---|---|
|
Rate of Post-Operative Complications
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from 6 months to 8 months following the procedureHistomorphometric measurements of the tissue fractions (newly formed bone, DBBM, autogenous bone, and marrow and/or connective tissue) will be performed for the grafted area.
Outcome measures
Outcome data not reported
Adverse Events
All Study Participants - d-PTFE
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
All Study Participants - Ti-mesh
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants - d-PTFE
n=10 participants at risk
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
d-PTFE: high-density polytetrafluoroethylene (d-PTFE) membrane
|
All Study Participants - Ti-mesh
n=10 participants at risk
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh: Titanium mesh
|
|---|---|---|
|
Injury, poisoning and procedural complications
Membrane exposure
|
10.0%
1/10 • Up to 8 months
|
20.0%
2/10 • Up to 8 months
|
|
Infections and infestations
abscess
|
10.0%
1/10 • Up to 8 months
|
0.00%
0/10 • Up to 8 months
|
Additional Information
Associate Professor
Tufts University School of Dental Medicine
Phone: 6176366659
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place