Clinical trial NCT00713206: Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
Official title: A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Disease
Partial Edentulism
Keywords: Dental implants, maxilla, sinus lift, augmentation
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Implants Not Mobile (Not Failing) at End of 3 Years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
measure: Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)
timeFrame: 3 year
Locations:
city: Chieti
country: Italy
facility: Università "G. d' Annunzio" Chieti-Pescara
Study officials:
affiliation: Director del Dipartimento di Scienze Odontostomatologiche
name: Sergio Caputi, DDS
role: PRINCIPAL_INVESTIGATOR
References: