Status:
COMPLETED
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
Lead Sponsor:
ZimVie
Conditions:
Tooth Disease
Partial Edentulism
Eligibility:
All Genders
18+ years
Phase:
NA
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 immediatel...
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 si...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00713206
Start Date
September 1 2006
End Date
August 1 2012
Last Update
July 13 2023
Active Locations (1)
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1
Università "G. d' Annunzio" Chieti-Pescara
Chieti, Italy