Denture, Complete, Immediate Dental Implant Loading
Conditions
Brief summary
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.
Interventions
DEVICENOVALOC TiN retained maxillary overdenture
4 implants immediately loaded by means of a NOVALOC TiN retained maxillary overdenture
Sponsors
Institut Straumann AG
West Virginia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fully edentulous maxilla * The implant site has to be healed for at least 4 months after extraction * Wearing complete dentures deemed adequate * Orthopantomogram available (OPT) * Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant * No bone grafting required * Implant IT ≥ 20 N/cm
Exclusion criteria
* Conditions requiring chronic routine prophylactic use of antibiotics * Conditions requiring prolonged use of steroids * History of leukocyte dysfunction and deficiencies * Bleeding disorders * History of neoplastic disease requiring use of radiation or chemotherapy * Metabolic bone disorders * Uncontrolled endocrine disorder * Use of any investigational drug or device within the 30-day period prior to implant surgery * Smoking more than 10 cigarettes a day * Alcoholism or drug abuse * Patient infected with HIV * Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability. Local
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Level (RBL) Change | Baseline to 6 months post implant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NOVALOC TiN 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 | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | NOVALOC TiN | — |
|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 13.4 | — |
| Diabetics | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Tobacco Use Status | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOVALOC TiN | Radiographic Bone Level (RBL) Change | 0.14 millimeters (mm) | Standard Deviation 0.36 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOVALOC TiN | Radiographic Bone Level (RBL) Change | 0.31 millimeters (mm) | Standard Error 0.73 |