Partial Edentulism, Tooth Disease
Conditions
Keywords
dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level, short fixed bridge, cost analysis
Brief summary
This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed. Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.
Detailed description
In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.
Interventions
DEVICEDental Implant (Nanotite)
Root form titanium dental implant
Sponsors
ZimVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of either sex and any race greater than 18 years of age * patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis * patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant * patients must be physically able to tolerate conventional surgical and restorative procedures
Exclusion criteria
* patients with active infection or severe inflammation in the areas intended for implant placement * patients with a \> 10 cigarettes per day smoking habit * patients with uncontrolled diabetes or metabolic bone disease * patient with a history of therapeutic radiation to the head * patients who are known to be pregnant * patients with para-functional habits with evidence of severe bruxing or clenching * patients not able to commit to a 3 year follow-up program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integration Success of Implant | 3 years | Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMariano A Sanz, MD, DDS
Universidad Complutense de Madrid
Participant flow
Recruitment details
Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began February 2009 and ended February 2011. All study patients were enrolled at 3 European Universities (dental clinics).
Participants by arm
| Arm | Count |
|---|---|
| Dental Implant (Nanotite) Dental implants of short length placed without sinus lifts | 17 |
| Control Group Dental implants of standard length placed simultaneously with sinus augmentation | 20 |
| Total | 37 |
Baseline characteristics
| Characteristic | Dental Implant (Nanotite) | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 18 Participants | 32 Participants |
| Region of Enrollment Greece | 3 participants | 6 participants | 9 participants |
| Region of Enrollment Italy | 9 participants | 10 participants | 19 participants |
| Region of Enrollment Spain | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 6 / 17 | 5 / 20 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 |
Outcome results
Primary
Integration Success of Implant
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Time frame: 3 years
Population: Number of participants used in analysis selected as per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dental Implant (Nanotite) | Integration Success of Implant | 17 participants |
| Control Group | Integration Success of Implant | 20 participants |