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CompletedNCT00725049RomeoUpdated Jul 28, 2026Results posted

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

An interventional study of Dental Implant (Nanotite) in Tooth Disease and Partial Edentulism, sponsored by ZimVie. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Tooth Disease
  • Partial Edentulism

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Keywords

  • dental implants
  • Nanotite Certain implant
  • Osseotite
  • multicenter
  • randomized
  • clinical study
  • partial edentulism
  • crestal bone level
  • short fixed bridge
  • cost analysis
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 37 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Dental implant (Nanotite)

    Dental implants of short length placed without sinus lifts

    Device: Dental Implant (Nanotite)

  • No intervention
    Control group

    Dental implants of standard length placed simultaneously with sinus augmentation

Interventions

  • DeviceDental Implant (Nanotite)

    Root form titanium dental implant

    Also known as: Nanotite

06

What researchers measure

Primary outcomes

  1. Integration Success of Implant

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

    Time frame: 3 years

07

Results

Posted Oct 11, 2013

Participant flow

Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began February 2009 and ended February 2011. All study patients were enrolled at 3 European Universities (dental clinics).

Participant flow — Overall Study
MilestoneDental Implant (Nanotite)Control Group
Started1720
Completed1720
Not completed00

Outcome measures

PrimaryIntegration Success of Implant

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

Time frame:
3 years
Reported as:
Number · participants
Integration Success of Implant
participantsDental Implant (Nanotite)Control Group
Integration Success of Implant1720

Adverse events

Collected over Adverse events are collected and reported from day 1 of the study to present time (entire duration of study).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dental Implant (Nanotite)—0/17 (0%)6/17 (35.3%)
Control Group—0/20 (0%)5/20 (25%)
Most frequent other events
Most frequent other events
EventDental Implant (Nanotite)Control Group
MobilitySurgical and medical procedures6/175/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dental Implant (Nanotite)Control GroupTotal
<=18 years000
Between 18 and 65 years141832
>=65 years325
Sex: Female, Male
Sex: Female, Male(Participants)Dental Implant (Nanotite)Control GroupTotal
Female61218
Male11819
Region of Enrollment
Region of Enrollment(participants)Dental Implant (Nanotite)Control GroupTotal
Spain549
Greece369
Italy91019
08

Study locations

1 site
  • Universidad Complutense de Madrid
    Madrid, 28040, Spain
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00725049
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Jul 30, 2008
Start date
Feb 2009
Primary completion
Jul 2013
Completion
Jul 2013
Results posted
Oct 11, 2013
Last update
Jul 28, 2026

Study contacts

Mariano A Sanz, MD, DDS
principal investigator · Universidad Complutense de Madrid

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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