Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

Dentsply

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Device: NobelSpeedy™ Replace®

Device: OsseoSpeed™

Device: NanoTite™ Certain® PREVAIL®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00820235

YA-OSS-0003

Details and patient eligibility

About

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

Enrollment

141 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of informed consent
At least 18 years
In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

Edentulous for at least 5 months at study site
A buccal-lingual bone width at study site of at least 5.5 mm
A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
A keratinized mid-buccal mucosal height of at least 2 mm at study site
Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss
Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
An opposing dentition with teeth, implants or prosthesis

Exclusion criteria

Insufficient interocclusal distance for implant placement and restoration at study site
Tooth adjacent (mesial and/or distal) to study site is ankylosed
More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
Untreated rampant caries and/or uncontrolled periodontal disease
Class II division 2 malocclusion (Edward Hartley Angle)
Use of tobacco within last 6 months
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
Use of any substance that will influence bone metabolism
Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
History of radiation in the head and neck region
Known pregnancy, pregnancy tests will be performed as per local requirements.
Unable or unwilling to return for follow-up visits for a period of 5 years
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 study center)
Previous enrollment or randomization of treatment in the present study.