Vertical Augmentation With Osteon at Dental Implant Placement

NCT01162629 | Unknown

• 1 other identifier: RED001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Injuries; Tooth Abnormalities

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Osteon

Patients requiring dental implants with deficient alveolar bone height

Device: Osteon bone graft

Interventions

Osteon bone graft DEVICE

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

Also known as: Osteon, Hydroxyapatite coated with beta-tricalcium phosphate, 100% synthetic bone graft

Osteon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Private specialist dental implant clinic

You may qualify if:

• missing one or two teeth
• bounded saddle
• healthy (ASA grade I \& II) adult

You may not qualify if:

• smoker
• significant medical problem (ASA III or above)

Sponsors & Collaborators

• Research and Education in Dentistry: lead

Study Sites (1)

Oracle Dental Clinics

Shrewsbury, Shropshire, SY1 3GW, United Kingdom

Location

MeSH Terms

Conditions

Tooth Injuries; Tooth Abnormalities; Anodontia; Tooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dental Pulp Diseases

Study Officials

• Richard J Oliver, BDS PhD

  Research and Education in Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard J Oliver, BDS PhD

CONTACT

00448453096323; richard.oliver@redonline.org

Jason Buglass, BDS

CONTACT

00441743 452369; jason@implantium.co.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 14, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

GB (1)