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Vertical Augmentation With Osteon at Dental Implant Placement

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

July 5, 2010
July 14, 2010
September 2010
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01162629 on ClinicalTrials.gov Archive Site
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Vertical Augmentation With Osteon at Dental Implant Placement
An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Private specialist dental implant clinic

  • Tooth Injuries
  • Tooth Abnormalities
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
Osteon
Patients requiring dental implants with deficient alveolar bone height
Intervention: Device: Osteon bone graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
September 2015
September 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
Yes
Contact: Richard J Oliver, BDS PhD 00448453096323 richard.oliver@redonline.org
Contact: Jason Buglass, BDS 00441743 452369 jason@implantium.co.uk
United Kingdom
 
NCT01162629
RED001
No
Dr Richard Oliver, Research and Education in Dentistry
Research and Education in Dentistry
Not Provided
Principal Investigator: Richard J Oliver, BDS PhD Research and Education in Dentistry
Research and Education in Dentistry
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP