Vertical Augmentation With Osteon at Dental Implant Placement

Tooth Injuries Clinical Trial

Official title:

An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01162629
• Other study ID #: RED001
• Status: Not yet recruiting
• Phase: N/A
• First received: July 5, 2010
• Last updated: July 14, 2010
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: July 2010
• Source: Research and Education in Dentistry
• Contact: Richard J Oliver, BDS PhD
• Phone: 00448453096323
• Email: richard.oliver[@]redonline.org
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tooth Abnormalities
• Tooth Injuries

Intervention

Device:
• Osteon bone graft
Osteon bone substitute placed to a height of 2 mm above the top of the dental implant

Locations

Country	Name	City	State
United Kingdom	Oracle Dental Clinics	Shrewsbury	Shropshire

Sponsors (1)

Lead Sponsor	Collaborator
Research and Education in Dentistry

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success of dental implants in alveolar bone augmented in the vertical direction with Osteon	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	No