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

Primary Purpose

Tooth Disease, Partial Edentulism

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Dental Implant (Osseotite)

About this trial

This is an interventional treatment trial for Tooth Disease focused on measuring Dental implants, maxilla, sinus lift, augmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Università "G. d' Annunzio" Chieti-Pescara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Dental implant (Osseotite)

Control group

Arm Description

Dental implants placed simultaneously with graft augmentation material.

Dental implants placed into graft augmentation material that has four months to heal.

Outcomes

Primary Outcome Measures

Implants Not Mobile (Not Failing) at End of 3 Years

All surviving implants at the end of study (3 years)

Secondary Outcome Measures

Full Information

NCT ID

NCT00713206

First Posted

July 9, 2008

Last Updated

July 11, 2023

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT00713206

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

September 2006 (Actual)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Disease, Partial Edentulism

Keywords

Dental implants, maxilla, sinus lift, augmentation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dental implant (Osseotite)

Arm Type

Active Comparator

Arm Description

Dental implants placed simultaneously with graft augmentation material.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Dental implants placed into graft augmentation material that has four months to heal.

Intervention Type

Device

Intervention Name(s)

Dental Implant (Osseotite)

Other Intervention Name(s)

Osseotite

Intervention Description

Root form titanium dental implant

Primary Outcome Measure Information:

Title

Implants Not Mobile (Not Failing) at End of 3 Years

Description

All surviving implants at the end of study (3 years)

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)

Description

Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame

Time Frame

3 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergio Caputi, DDS

Organizational Affiliation

Director del Dipartimento di Scienze Odontostomatologiche

Official's Role

Principal Investigator

Facility Information:

Facility Name

Università "G. d' Annunzio" Chieti-Pescara

City

Chieti

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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