An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation

NCT ID: NCT00725049

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-07-31

Brief Summary

This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed.

Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

Detailed Description

In this randomized study, patients needing restorations in the posterior maxilla will be randomly assigned to the short implant group (test) or the standard length and augmentation group (control). All implants will be placed using a two-stage approach with healing abutments placed at three months and temporary prosthesis at four months following implant and/ or sinus augmentation surgery. Time, materials, and efforts associated with treating test and control cases will be documented to allow an assessment of the costs incurred with each approach.

Conditions

Tooth Disease; Partial Edentulism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dental implant (Nanotite)

Dental implants of short length placed without sinus lifts

Group Type: ACTIVE_COMPARATOR

Dental Implant (Nanotite)

Intervention Type: DEVICE

Root form titanium dental implant

Control group

Dental implants of standard length placed simultaneously with sinus augmentation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dental Implant (Nanotite)

Root form titanium dental implant

Intervention Type: DEVICE

Other Intervention Names

Nanotite

Eligibility Criteria

Inclusion Criteria

• patients of either sex and any race greater than 18 years of age
• patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis
• patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant
• patients must be physically able to tolerate conventional surgical and restorative procedures

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 or metabolic bone disease
• patient with a history of therapeutic radiation to the head
• patients who are known to be pregnant
• patients with para-functional habits with evidence of severe bruxing or clenching
• patients not able to commit to a 3 year follow-up program

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZimVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano A Sanz, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

2611

Identifier Type: -

Identifier Source: org_study_id