Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

Dentsply

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.

Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00746187

YA-MIC-0003

Details and patient eligibility

About

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.

Enrollment

36 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent
Age 18 - 75 years
Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
Edentulous in the area/s if implant placement for more than 2 months

Exclusion criteria

Untreated caries and/or periodontal disease of residual dentition
Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
Absence of occlusal stability in centric occlusion
Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
Pregnancy
Present alcohol or drug abuse
Tobacco smoking during the last 6 months
Unable or unwilling to return for follow-up visits for a period of 3 years