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Vertical Augmentation With Osteon at Dental Implant Placement

This study is not yet open for participant recruitment.
Verified July 2010 by Research and Education in Dentistry
Sponsor:
Information provided by:
Research and Education in Dentistry
ClinicalTrials.gov Identifier:
NCT01162629
First received: July 5, 2010
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
  Purpose

Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.


Condition Intervention
Tooth Injuries
Tooth Abnormalities
 Device: Osteon bone graft

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Further study details as provided by Research and Education in Dentistry:

Primary Outcome Measures:
  • The success of dental implants in alveolar bone augmented in the vertical direction with Osteon [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The implants will be deemed successful at each time point if the radiographic bone level remains at 2 mm above the level of the implant, i.e. at the same height as when placed. Given that we know precisely the dimensions of the abutments placed in the implant, this provides the necessary calibration in order to undertake this assessment. If the bone level is lost, the procedure will be deemed to have failed.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Osteon
Patients requiring dental implants with deficient alveolar bone height
 Device: Osteon bone graft
Osteon bone substitute placed to a height of 2 mm above the top of the dental implant
Other Names:
  • Osteon
  • Hydroxyapatite coated with beta-tricalcium phosphate
  • 100% synthetic bone graft

Detailed Description:

Primary Objective

• To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.

Secondary Objectives • To determine the long term success of dental implants in this augmented bone.

Primary Endpoint

• Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Private specialist dental implant clinic

Criteria

Inclusion Criteria:

  • missing one or two teeth
  • bounded saddle
  • healthy (ASA grade I & II) adult

Exclusion Criteria:

  • smoker
  • significant medical problem (ASA III or above)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162629

Contacts
Contact: Richard J Oliver, BDS PhD 00448453096323 richard.oliver@redonline.org
Contact: Jason Buglass, BDS 00441743 452369 jason@implantium.co.uk

Locations
United Kingdom
Oracle Dental Clinics Not yet recruiting
Shrewsbury, Shropshire, United Kingdom, SY1 3GW
Sponsors and Collaborators
Research and Education in Dentistry
Investigators
Principal Investigator: Richard J Oliver, BDS PhD Research and Education in Dentistry
  More Information

No publications provided

Responsible Party: Dr Richard Oliver, Research and Education in Dentistry
ClinicalTrials.gov Identifier: NCT01162629     History of Changes
Other Study ID Numbers: RED001
Study First Received: July 5, 2010
Last Updated: July 14, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Research and Education in Dentistry:
bounded saddles
missing teeth
dental implants
Tooth, Nonvital

Additional relevant MeSH terms:
Congenital Abnormalities
Tooth Abnormalities
Tooth Injuries
Stomatognathic System Abnormalities
 Stomatognathic Diseases
Tooth Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013