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

Partial Edentulism Clinical Trial

— Romeo  

Official title:

A Prospective, Multicenter, Randomized Multicenter Study of Short Implants Used to Obviate the Need for Sinus Augmentation: an Assessment of Clinical Outcomes and Resource Allocation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725049
• Other study ID #: 2611
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: July 2013

Study information

• Verified date: March 2022
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• Dental Implant (Nanotite)
Root form titanium dental implant

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integration Success of Implant	Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.	3 years