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

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.

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.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism; Tooth Disease
• Intervention / Treatment: Device: Dental Implant (Nanotite)

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dental implant (Nanotite); Dental implants of short length placed without sinus lifts	Device: Dental Implant (Nanotite); Root form titanium dental implant; Other Names: Nanotite
No Intervention: Control group; Dental implants of standard length placed simultaneously with sinus augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integration Success of Implant	Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Benefit Analysis	In addition to clinical outcomes, the treatment groups will also be evaluated based on total cost of treatment. Because of differences in currencies and the manner in which materials and services are calculated, the resources needed will be quantified. "Resources" includes the variables of time, effort, and materials: "time" = how much time clinician devotes to the treatment of the case directly; also the time patients may lose from work or other duties while receiving treatment; Time includes the number of clinic visits, total chair time, and total clinician time. "Effort" is a subjective factor in terms of the type of procedure performed by the clinicians and by the need for patients to adjust to the discomforts of their treatment. "Materials" includes all devices employed, medications, and adjunctive services such as lab fees; includes interventions to treat complications or other unscheduled treatments.	3 years

Collaborators and Investigators

• Sponsor: ZimVie
• Investigators: Principal Investigator: Mariano A Sanz, MD, DDS, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimated): July 30, 2008

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: multicenter; randomized; dental implants; clinical study; crestal bone level; cost analysis; Nanotite Certain implant; Osseotite; partial edentulism; short fixed bridge
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: 2611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO