Vertical Augmentation With Osteon at Dental Implant Placement

Research and Education in Dentistry

Status: Unknown

Conditions: Tooth Injuries; Tooth Abnormalities

Treatments: Device: Osteon bone graft

Study type: Observational

Funder types: Other

Identifiers

NCT01162629

RED001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Osteon

Description:

Patients requiring dental implants with deficient alveolar bone height

Treatment:

Device: Osteon bone graft