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

ZimVie

Status

Completed

Conditions

Tooth Disease

Partial Edentulism

Treatments

Device: Dental Implant (Nanotite)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00725049

2611

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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