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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01162629
Enrollment
100
Registered
2010-07-14
Start date
2010-09-30
Completion date
2015-09-30
Last updated
2010-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Abnormalities, Tooth Injuries

Keywords

bounded saddles, missing teeth, dental implants, Tooth, Nonvital

Brief summary

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.

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.

Interventions

DEVICEOsteon bone graft

Osteon bone substitute placed to a height of 2 mm above the top of the dental implant

Sponsors

Research and Education in Dentistry
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon3 yearsThe 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.

Countries

United Kingdom

Contacts

Primary ContactRichard J Oliver, BDS PhD
richard.oliver@redonline.org00448453096323
Backup ContactJason Buglass, BDS
jason@implantium.co.uk00441743 452369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026