N/A
N=37
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
Tooth Disease · Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT00725049 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Integration Success of Implant — 17; 20 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental Implant (Nanotite) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZimVie
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Integration Success of Implant |
17; 20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00725049). 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.