Trial Outcomes & Findings for Mandibular Overdenture Clinical Trial Comparing Parallel Sided and Tapered Dental Implants (NCT NCT03272828)
NCT ID: NCT03272828
Last Updated: 2024-01-09
Results Overview
Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact).
COMPLETED
NA
48 participants
From implant placement (baseline) to 5 years
2024-01-09
Participant Flow
Participants were recruited via flyers posted in the School of Dentistry. A total of 63 people were screened for eligibility and 48 met the inclusion criteria.
Of 48 eligible participants who signed the consent form and were enrolled in the study, one declined study participation due to lack of willingness to pay for the required cone beam computed tomography (CBCT) pre-surgical procedure. Participants were randomized to implant group the day of surgery.
Participant milestones
| Measure |
Parallel Sided Implant Group
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Parallel Sided Implant Group
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Deceased
|
1
|
1
|
|
Overall Study
Failed implant
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Parallel Sided Implant Group
n=24 Participants
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
n=23 Participants
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.17 years
n=24 Participants
|
61.74 years
n=23 Participants
|
61.45 years
n=47 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=24 Participants
|
11 Participants
n=23 Participants
|
26 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
21 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
47 Participants
n=47 Participants
|
|
Implant stability quotient (ISQ)
|
82.75 units on a scale
STANDARD_DEVIATION 2.75 • n=24 Participants
|
81.30 units on a scale
STANDARD_DEVIATION 3.65 • n=23 Participants
|
82.04 units on a scale
STANDARD_DEVIATION 3.27 • n=47 Participants
|
PRIMARY outcome
Timeframe: From implant placement (baseline) to 5 yearsPopulation: All participants who had an implant placed at the midline of the mandibular arch and their mandibular denture fitted for immediate wearing.
Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact).
Outcome measures
| Measure |
Parallel Sided Implant Group
n=24 Participants
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
n=23 Participants
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Participants continuing in the study at 5 years
The implant stability quotient (ISQ) value is a measurement of the mechanical implant stability in the bone and is measured directly after surgical implant placement and then at follow-ups. It is obtained by resonance frequency with a device that sends out a signal to a metal rod placed in the implant and then reads the value of the signal when it bounces back. The value ranges from 0 to 100 with higher values indicating better bone-to-implant contact and greater stability.
Outcome measures
| Measure |
Parallel Sided Implant Group
n=13 Participants
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
n=13 Participants
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Implant Stability Quotient (ISQ) Measured at 5 Years
|
80.77 units on a scale
Standard Deviation 5.82
|
85.54 units on a scale
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: From implant placement (baseline) to 5 yearsPopulation: Participants continuing in the study at 5 years
The measure of bone loss in millimeters (mm) around the implant at 5 years compared to bone height at baseline. Changes in bone level are measured on intraoral radiographs and compared with the bone level measure immediately after surgical implant placement (baseline). The implant platform was used as the reference point and measurements of the bone were made to the nearest thread. The bone level is measured on both sides (mesial \& distal) of the implant using the thread on the implant as reference. The distance between the threads is 0.6 mm.
Outcome measures
| Measure |
Parallel Sided Implant Group
n=13 Participants
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
n=13 Participants
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Bone Loss Measurement at 5 Years
|
1.02 millimeters
Standard Deviation 1.37
|
0.65 millimeters
Standard Deviation 1.08
|
Adverse Events
Parallel Sided Implant Group
Tapered Shaped Implant Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Parallel Sided Implant Group
n=24 participants at risk
A Parallel sided titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
Tapered Shaped Implant Group
n=23 participants at risk
A tapered shaped titanium dental implant will be placed in the edentulous mandible.
Nobel Biocare titanium dental implants
|
|---|---|---|
|
Gastrointestinal disorders
Implant failure
|
4.2%
1/24 • 5 years
|
8.7%
2/23 • 5 years
|
|
Psychiatric disorders
Participant wanted implant removed
|
4.2%
1/24 • 5 years
|
0.00%
0/23 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place