Partial Edentulism, Tooth Disease
Conditions
Keywords
Dental implants, maxilla, sinus lift, augmentation
Brief summary
This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases. Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.
Detailed description
This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side. Each patient (or side if a bilateral case) will be randomly assigned to one of two groups: Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.
Interventions
DEVICEDental Implant (Osseotite)
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 for whom a decision has already been made to augment one or both maxillary sinuses for the purpose of placing dental implants in a maxillary ridge no less than 3 mm high and no greater than 5 mm in height * Patients must be physically able to tolerate conventional surgical and restorative procedures. * Patients must agree to be evaluated for each study visit, especially the yearly follow-up visit
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 mellitus. * Treatment with therapeutic radiation to the head within the past 12 months. * Patients who are pregnant at the screening visit. * Patients with evidence of severe para-functional habits such as bruxing or clenching.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implants Not Mobile (Not Failing) at End of 3 Years | 3 years | All surviving implants at the end of study (3 years) |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORSergio Caputi, DDS
Director del Dipartimento di Scienze Odontostomatologiche
Participant flow
Recruitment details
Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Dental implants placed simultaneously with graft augmentation material. | 62 |
| Control Group Dental implants placed into graft augmentation material that has four months to heal. | 30 |
| Total | 92 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 23 Participants | 83 Participants |
| Region of Enrollment Italy | 44 participants | 19 participants | 63 participants |
| Region of Enrollment Portugal | 9 participants | 6 participants | 15 participants |
| Region of Enrollment Spain | 9 participants | 5 participants | 14 participants |
| Sex: Female, Male Female | 28 Participants | 17 Participants | 45 Participants |
| Sex: Female, Male Male | 34 Participants | 13 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 2 / 65 | 1 / 57 |
| serious Total, serious adverse events | 0 / 65 | 0 / 57 |
Outcome results
Primary
Implants Not Mobile (Not Failing) at End of 3 Years
All surviving implants at the end of study (3 years)
Time frame: 3 years
Population: dental implants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | Implants Not Mobile (Not Failing) at End of 3 Years | 158 dental implant |
| Control Group | Implants Not Mobile (Not Failing) at End of 3 Years | 140 dental implant |
Other Pre-specified
Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)
Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame
Time frame: 3 year