Tooth DiseaseRomeoNCT00725049
An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation
A study testing Dental Implant (Nanotite) in people with Tooth Disease and Partial Edentulism, run by ZimVie at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Disease, Partial Edentulism
- What is being tested?
- Dental Implant (Nanotite)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Dental Implant (Nanotite)
- Keywords
- dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level, short fixed bridge, cost analysis
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant (Nanotite)Device
Also called Nanotite
Root form titanium dental implant
| Study group | Role | What they receive |
|---|---|---|
| Dental implant (Nanotite) | Active comparator | Dental implants of short length placed without sinus lifts Receives: Device: Dental Implant (Nanotite) |
| Control group | No intervention | Dental implants of standard length placed simultaneously with sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integration Success of Implant
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano A Sanz, MD, DDS, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725049
- Sponsor's protocol ID
- 2611
- Acronym
- Romeo
- Status last verified
- Mar 2022
- First submitted
- 28 Jul 2008
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00725049
- Acronym / sponsor ID
- Romeo / 2611
- Conditions
- Tooth Disease, Partial Edentulism
- Keywords
- dental implants, Nanotite Certain implant, Osseotite, multicenter, randomized, clinical study, partial edentulism, crestal bone level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- Feb 2009 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental implant (Nanotite) | Active comparator | Device: Dental Implant (Nanotite)Dental implants of short length placed without sinus lifts |
| Control group | No intervention | –Dental implants of standard length placed simultaneously with sinus augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Implant (Nanotite)Also: NanotiteRoot form titanium dental implant | Device | Dental implant (Nanotite) |
Primary outcome
Integration Success of Implant
Time frame: 3 years
Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano A Sanz, MD, DDS principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant (Nanotite) in people with Tooth Disease and Partial Edentulism, run by ZimVie at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integration Success of Implant (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.