N/A
N=122
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
Tooth Disease · Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT00713206 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Implants Not Mobile (Not Failing) at End of 3 Years — 158; 140 dental implant
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental Implant (Osseotite) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZimVie
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implants Not Mobile (Not Failing) at End of 3 Years |
158; 140 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00713206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.