Vertical Augmentation With Osteon at Dental Implant Placement

• Conditions: Tooth Injuries; Tooth Abnormalities
• Interventions: Device: Osteon bone graft

• Registration Number: NCT01162629
• Lead Sponsor: Research and Education in Dentistry

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.

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-05
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-15
• Study Start: 2010-09
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteon	Osteon bone graft	Patients requiring dental implants with deficient alveolar bone height

Primary Outcome Measures

Name	Time	Method
The success of dental implants in alveolar bone augmented in the vertical direction with Osteon	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.

Trial Locations

Locations (1)

Oracle Dental Clinics; 🇬🇧 Shrewsbury, Shropshire, United Kingdom