Trial Outcomes & Findings for Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System (NCT NCT06083506)
NCT ID: NCT06083506
Last Updated: 2025-07-20
Results Overview
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
COMPLETED
NA
17 participants
Baseline to 6 months post implant
2025-07-20
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
NOVALOC TiN
Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.
|
|---|---|
|
Overall Study
STARTED
|
17 68
|
|
Overall Study
COMPLETED
|
14 56
|
|
Overall Study
NOT COMPLETED
|
3 12
|
Reasons for withdrawal
| Measure |
NOVALOC TiN
Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NOVALOC TiN
n=14 Participants
Each subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.
NOVALOC TiN retained maxillary overdenture: 4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 13.4 • n=14 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=14 Participants
|
|
Diabetics
|
4 Participants
n=14 Participants
|
|
Tobacco Use Status
|
1 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post implantRBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Outcome measures
| Measure |
NOVALOC TiN
n=56 Implants
Each subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.
NOVALOC TiN retained maxillary overdenture: 4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
|
|---|---|
|
Radiographic Bone Level (RBL) Change
|
0.14 millimeters (mm)
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: Baseline to 12 months post implantRBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
Outcome measures
| Measure |
NOVALOC TiN
n=56 Implants
Each subject will receive 4 implants. Implants will be placed flapless using a guided surgical protocol and will be immediately loaded by means of a NOVALOC TiN retained maxillary overdenture.
NOVALOC TiN retained maxillary overdenture: 4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
|
|---|---|
|
Radiographic Bone Level (RBL) Change
|
0.31 millimeters (mm)
Standard Error 0.73
|
Adverse Events
NOVALOC TiN
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place