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

NCT00713206 | Completed Results DMC

• 1 other identifier: 2604
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Disease; Partial Edentulism

Keywords

Dental implants, maxilla, sinus lift, augmentation

Outcome Measures

Primary Outcomes (1)

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

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

  3 years

Other Outcomes (1)

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

  3 year

Study Arms (2)

Dental implant (Osseotite)

ACTIVE COMPARATOR

Dental implants placed simultaneously with graft augmentation material.

Device: Dental Implant (Osseotite)

Control group

NO INTERVENTION

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

Interventions

Dental Implant (Osseotite) DEVICE

Root form titanium dental implant

Also known as: Osseotite

Dental implant (Osseotite)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZimVie: lead

Study Sites (1)

Università "G. d' Annunzio" Chieti-Pescara

Chieti, Italy

Location

MeSH Terms

Conditions

Tooth Diseases

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Biomet 3i LLC

cristina.matthews@biomet.com

5617766722

Study Officials

• Sergio Caputi, DDS

  Director del Dipartimento di Scienze Odontostomatologiche

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: September 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 13, 2023
• Results First Posted: October 11, 2013

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)