An interventional study of NOVALOC TiN retained maxillary overdenture in Immediate Dental Implant Loading and Denture, Complete, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by West Virginia University · Not applicable, Interventional, and Treatment
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.
West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
Local exclusion criteria:
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.
Device: NOVALOC TiN retained maxillary overdenture
4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
Radiographic Bone Level (RBL) Change
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.
Time frame: Baseline to 6 months post implant
Radiographic Bone Level (RBL) Change
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.
Time frame: Baseline to 12 months post implant
| Milestone | NOVALOC TiN |
|---|---|
| Started | 17 |
| Completed | 14 |
| Not completed | 3 |
| Withdrew: Physician decision | 2 |
| Withdrew: Lack of efficacy | 1 |
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.
| millimeters (mm) | NOVALOC TiN |
|---|---|
| Radiographic Bone Level (RBL) Change | 0.14 ± 0.36 |
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.
| millimeters (mm) | NOVALOC TiN |
|---|---|
| Radiographic Bone Level (RBL) Change | 0.31 ± 0.73 |
Collected over 12 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NOVALOC TiN | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | NOVALOC TiN |
|---|---|
| Mean | 64.2 ± 13.4 |
| Sex: Female, Male(Participants) | NOVALOC TiN |
|---|---|
| Female | 2 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | NOVALOC TiN |
|---|
| Diabetics(Participants) | NOVALOC TiN |
|---|---|
| Count of participants | 4 |
| Tobacco Use Status(Participants) | NOVALOC TiN |
|---|---|
| Count of participants | 1 |
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West Virginia University