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OpenTrials
Completed

NCT Number: NCT00725049

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental Implant (Nanotite)

Device

Root form titanium dental implant

Other names: Nanotite

Primary outcomes

  1. Integration Success of Implant

    Time frame: 3 years

    Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study 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.

Acronym: Romeo

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2008
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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