Trial Outcomes & Findings for Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability (NCT NCT04121364)
NCT ID: NCT04121364
Last Updated: 2024-02-21
Results Overview
The primary endpoint is a composite measure of implant success (after criteria of Buser, et. al.1) at six-month post-functional loading consisting of: * Presence of the implant at its site of implantation; and, * Absence of a recurrent peri-implant infection with suppuration; and, * Absence of mobility, defined as: * Lack of implant rotation subjected to 20 Ncm of clockwise torque applied 15 minutes after implant placement; and. * Lack of implant rotation subjected to 35 Ncm of clockwise torque applied 13 weeks after implant placement; and, * No construct mobility upon palpation at 6 months post-functional loading; and, * Absence of encapsulation defined as continuous radiolucency around the implant in a periapical radiograph.
COMPLETED
20 participants
6 months
2024-02-21
Participant Flow
Participant milestones
| Measure |
Tetranite
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Tetranite: Dental Adhesive for increased implant stability
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability
Baseline characteristics by cohort
| Measure |
Tetranite
n=20 Participants
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Tetranite: Dental Adhesive for increased implant stability
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Age, Continuous
|
56.05 years
STANDARD_DEVIATION 13.51 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Surviving implants assessed. Number of subjects meeting the criteria reported
The primary endpoint is a composite measure of implant success (after criteria of Buser, et. al.1) at six-month post-functional loading consisting of: * Presence of the implant at its site of implantation; and, * Absence of a recurrent peri-implant infection with suppuration; and, * Absence of mobility, defined as: * Lack of implant rotation subjected to 20 Ncm of clockwise torque applied 15 minutes after implant placement; and. * Lack of implant rotation subjected to 35 Ncm of clockwise torque applied 13 weeks after implant placement; and, * No construct mobility upon palpation at 6 months post-functional loading; and, * Absence of encapsulation defined as continuous radiolucency around the implant in a periapical radiograph.
Outcome measures
| Measure |
Tetranite
n=9 Participants
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Tetranite: Dental Adhesive for increased implant stability
|
|---|---|
|
Implant Success (Modified Buser Criteria)
|
6 participants
|
SECONDARY outcome
Timeframe: 12 monthsIncidence of Device related Serious adverse events
Outcome measures
Outcome data not reported
Adverse Events
Tetranite
Serious adverse events
| Measure |
Tetranite
n=20 participants at risk
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Tetranite: Dental Adhesive for increased implant stability
|
|---|---|
|
Infections and infestations
Implant Loss
|
65.0%
13/20 • Number of events 13 • Adverse event data were collected throughout the study: from device/implant placement through the 24 month post-loading follow-up. Additionally, patients who experienced an implant failure were followed for adverse events through 12 months post-implant failure.
|
Other adverse events
| Measure |
Tetranite
n=20 participants at risk
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Tetranite: Dental Adhesive for increased implant stability
|
|---|---|
|
Infections and infestations
Suppuration
|
20.0%
4/20 • Number of events 10 • Adverse event data were collected throughout the study: from device/implant placement through the 24 month post-loading follow-up. Additionally, patients who experienced an implant failure were followed for adverse events through 12 months post-implant failure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60