Vertical Augmentation With Osteon at Dental Implant Placement

July 14, 2010 updated by: Research and Education in Dentistry

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom, SY1 3GW
        • Oracle Dental Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Private specialist dental implant clinic

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
Time Frame: 3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research and Education in Dentistry

Investigators

  • Principal Investigator: Richard J Oliver, BDS PhD, Research and Education in Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

July 5, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 14, 2010

Study Record Updates

Last Update Posted (Estimate)

July 15, 2010

Last Update Submitted That Met QC Criteria

July 14, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RED001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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