Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)

ZimVie

Status

Completed

Conditions

Tooth Disease

Partial Edentulism

Treatments

Device: Dental Implant (Osseotite)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00713206

2604

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.