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

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

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Tooth Disease
• Intervention / Treatment: Device: Dental Implant (Osseotite)

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy
    • Università "G. d' Annunzio" Chieti-Pescara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dental implant (Osseotite); Dental implants placed simultaneously with graft augmentation material.	Device: Dental Implant (Osseotite); Root form titanium dental implant; Other Names: Osseotite
No Intervention: Control group; Dental implants placed into graft augmentation material that has four months to heal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implants Not Mobile (Not Failing) at End of 3 Years	All surviving implants at the end of study (3 years)	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ZimVie
• Investigators: Principal Investigator: Sergio Caputi, DDS, Director del Dipartimento di Scienze Odontostomatologiche

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimated): July 11, 2008

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Dental implants, maxilla, sinus lift, augmentation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: 2604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO