Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone

Dentsply

Status

Completed

Conditions

Edentulism

Treatments

Device: ASTRA TECH Implant System, OsseoSpeed™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00807456

YA-PRO-0001

Details and patient eligibility

About

The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.

The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.

Enrollment

65 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of informed consent
Aged 18-75 years at enrolment
A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
History of edentulism in the study area of at least 3 months
Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

Uncontrolled pathological processes in the oral cavity
Known or suspected current malignancy
History of radiation therapy in the head and neck region
History of chemotherapy within 5 years prior to surgery
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Uncontrolled diabetes mellitus
Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
Smoking more than 10 cigarettes per day
Present alcohol and/or drug abuse
Current need for bone grafting in the planned implant area
Previous enrolment in the present study
Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)
Unlikely to be able to comply with study procedures, as judged by the investigator