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Status unknownNCT02178891Updated Jul 1, 2014

Extra Short Implants Brånemark System® RP Ø4.5x4.5 mm Implants

An interventional study of extra short implant in Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration, sponsored by Nobel Biocare. Status unknown at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-01.

Sponsored by Nobel Biocare · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

An extra short, 2-piece implant with a Brånemark hexagon interface was developed with a bone anchoring length of only 4.5 mm, for subjects with severely resorbed jaws.

02

Conditions studied

  • Healthy Volunteers With Severely Resorbed Jaws in Need of an Implant Supported Restoration

Keywords

  • short implants
  • Nobel Biocare
  • partially edentulous
  • maxilla or mandible
03

In context

Lead sponsor

Nobel Biocare is the lead sponsor of 20 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
Yes

Inclusion criteria

  • The subject should be at least 18 years of age and have passed secession of growth
  • The subject should be in need of an implant-supported restoration in the posterior region of the mouth (maxilla: first premolar to third molar, mandible: first premolar to second molar, not third molar due to mobile gingiva), where at least 2 implants are needed of which at least one should be an Extra Short Implant
  • Obtained informed consent from the subject
  • The subject must be in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems
  • The subject should have a severely resorbed posterior mandible and/ or maxilla.
  • Implants are only to be placed in healed sites, defined as a site with minimum 6 months of healing following tooth extraction
  • At least 6 mm residual bone width, between 4-7 mm residual bone height in the maxilla and between 6-9 mm residual bone height in the mandible
  • At implant installation the implant should be stable; final tightening torque of the implant about 25 Ncm or higher, preferably not exceeding 45 Ncm
  • The subject should be healthy and compliant with good oral hygiene
  • Favorable and stable occlusal relationship

Exclusion criteria

Exclusion Criteria:

  • The subject is not able to give her/his informed consent of participating
  • Health conditions, which do not permit the surgical treatment
  • Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in subject records or in subject history
  • Any disorders in the planned implant area such as previous tumours, chronic bone disease or previous irradiation
  • Alcohol or drug abuse as noted in subject records or in subject history.
  • Heavy smoking (>10 cigarettes/day)
  • Intake of medication containing bisphosphonates
  • Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake
  • Severe bruxism or other destructive habits
  • Immediate insertion (i.e. placement of the implant immediately after extraction)
  • Bone augmentation procedures before or at implant installation is not allowed
  • Deviation from stated drilling protocol, utilizing osteotomes, is not allowed
  • Lack of opposing dentition
  • Single crown restorations are not to be performed in the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Other
    short implants

    Device: extra short implant

Interventions

  • Deviceextra short implant
06

What researchers measure

Primary outcomes

  1. marginal bone level changes

    Time frame: yearly, up to 5 years

Secondary outcomes

  1. cumulative survival and success rates

    Time frame: yearly, up to 5 years

Other outcomes

  1. difference between maxilla and mandible

    Time frame: yearly, up to 5 years

07

Study locations

2 sites
  • Universtätsmedizin Mainz
    Mainz, Rhl-Palat. 55131, Germany
  • Universitätsmedizin Mainz
    Mainz, 55131, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02178891
Lead sponsor
Nobel Biocare
Responsible party
Sponsor
First posted
Jul 1, 2014
Start date
Jan 2010
Primary completion
Dec 2018 (estimated)
Completion
Aug 2019 (estimated)
Last update
Jul 1, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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