Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

Dentsply

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Device: OsseoSpeed™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00711282

YA-OSS-0009

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent
At least 18 years at inclusion
At least 20 teeth with expected functional balanced occlusion after restoration
In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25
Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest
Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants

Exclusion criteria

Untreated rampant caries and uncontrolled periodontal disease
Absence of adjacent (mesial and/or distal) natural tooth root
Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent / non-insulin dependent Diabetes Mellitus)
Current alcohol or drug abuse
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
History of radiation in the head and neck region
History of chemotherapy within 5 years prior to surgery
Unable or unwilling to return for follow-up visits for a period of 3 years and 6 months
Unrealistic esthetic demands
Unlikely to be able to comply with study procedures according to Investigators judgement
Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the investigational site)
Previous enrolment in this study