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

Partial Edentulism Clinical Trial

Official title:

A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713206
• Other study ID #: 2604
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: August 2012

Study information

• Verified date: July 2023
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• Dental Implant (Osseotite)
Root form titanium dental implant

Locations

Country	Name	City	State
Italy	Università "G. d' Annunzio" Chieti-Pescara	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)	Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame	3 year
Primary	Implants Not Mobile (Not Failing) at End of 3 Years	All surviving implants at the end of study (3 years)	3 years