Trial Outcomes & Findings for Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) (NCT NCT04144322)
NCT ID: NCT04144322
Last Updated: 2025-05-06
Results Overview
Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Short Implant
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Short Implant
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Short Implant
n=15 Participants
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=15 Participants
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.67 years
STANDARD_DEVIATION 14.57 • n=15 Participants
|
56.87 years
STANDARD_DEVIATION 13.31 • n=15 Participants
|
57.76 years
STANDARD_DEVIATION 13.99 • n=30 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
14 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Soft tissue phenotype
Thin
|
1 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
4 Participants
n=30 Participants
|
|
Soft tissue phenotype
Medium
|
5 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
12 Participants
n=30 Participants
|
|
Soft tissue phenotype
Thick
|
3 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=30 Participants
|
|
Soft tissue phenotype
Very Thick
|
6 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
9 Participants
n=30 Participants
|
|
Bone density
D1
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Bone density
D2
|
0 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=30 Participants
|
|
Bone density
D3
|
15 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
28 Participants
n=30 Participants
|
|
Bone density
D4
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Residual ridge height
|
5.74 millimeters
STANDARD_DEVIATION 0.84 • n=15 Participants
|
6.39 millimeters
STANDARD_DEVIATION 1.53 • n=15 Participants
|
6.07 millimeters
STANDARD_DEVIATION 1.26 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 monthsComparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.
Outcome measures
| Measure |
Short Implant
n=15 Participants
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=15 Participants
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Change in Mesial-distal (M-D) Bone Loss
Surgery visit
|
0.63 millimeters
Standard Deviation 0.38
|
0.61 millimeters
Standard Deviation 0.57
|
|
Change in Mesial-distal (M-D) Bone Loss
4 months (second stage)
|
-0.41 millimeters
Standard Deviation 0.76
|
-0.40 millimeters
Standard Deviation 1.04
|
|
Change in Mesial-distal (M-D) Bone Loss
5 months (loading)
|
-0.55 millimeters
Standard Deviation 0.83
|
-0.64 millimeters
Standard Deviation 0.75
|
|
Change in Mesial-distal (M-D) Bone Loss
12 months
|
-0.74 millimeters
Standard Deviation 0.79
|
-0.40 millimeters
Standard Deviation 0.57
|
|
Change in Mesial-distal (M-D) Bone Loss
24 months
|
-0.84 millimeters
Standard Deviation 0.62
|
-059 millimeters
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 5 month post-op, 12 month post-op, and 24 month post-op visitsThe survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment.
Outcome measures
| Measure |
Short Implant
n=17 Participants
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=17 Participants
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Survival Rate
5 months (loading)
|
17 Participants
|
15 Participants
|
|
Survival Rate
12 months
|
17 Participants
|
15 Participants
|
|
Survival Rate
24 months
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 5 month post-op, 12 month post-op, and 24 month post-op visitsThe number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
Outcome measures
| Measure |
Short Implant
n=15 Participants
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=15 Participants
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Number of Sites With Bleeding on Probing
5 months (loading)
|
.03 implant sites
Standard Deviation .02
|
.08 implant sites
Standard Deviation .05
|
|
Number of Sites With Bleeding on Probing
12 months
|
.14 implant sites
Standard Deviation .05
|
.39 implant sites
Standard Deviation .09
|
|
Number of Sites With Bleeding on Probing
24 months
|
.35 implant sites
Standard Deviation .07
|
.32 implant sites
Standard Deviation .08
|
SECONDARY outcome
Timeframe: 5 month post-op, 12 month post-op, and 24 month post-op visitsThe probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
Outcome measures
| Measure |
Short Implant
n=15 Participants
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=15 Participants
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Probing Pocket Depth
5 months (loading)
|
2.84 millimeters
Standard Deviation 0.15
|
2.94 millimeters
Standard Deviation .15
|
|
Probing Pocket Depth
12 months
|
3.32 millimeters
Standard Deviation 0.14
|
3.27 millimeters
Standard Deviation .15
|
|
Probing Pocket Depth
24 months
|
3.79 millimeters
Standard Deviation 0.16
|
3.72 millimeters
Standard Deviation .16
|
Adverse Events
Short Implant
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Implant
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Short Implant
n=17 participants at risk
17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant
|
Long Implant
n=17 participants at risk
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
0.00%
0/17 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
|
Cardiac disorders
Coronavirus disease of 2019 and ablation
|
0.00%
0/17 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
|
Social circumstances
Vehicle accident
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
0.00%
0/17 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
|
Social circumstances
Assault
|
0.00%
0/17 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
|
Musculoskeletal and connective tissue disorders
Hip replacement
|
0.00%
0/17 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place