Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

Dentsply

Status: Completed

Conditions: Jaw, Edentulous, Partially

Treatments: Device: Astra Tech Fixture ST

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748241

YA-MIC-0002

Details and patient eligibility

About

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 75
• Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
• Willing to give informed consent

Exclusion criteria

• Bone height < 5 mm, in the planned implant area
• Bone width < 5 mm, in the planned implant area
• Previous bone augmentation procedure in the planned implant area
• Previous failures of endosseous implants
• Untreated caries and/or periodontal disease of residual dentition
• History or presence of 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
• Current alcohol or drug abuse
• Unable or unwilling to return for follow-up visits for 3 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Astra Tech Fixture ST

Experimental group

Treatment:

Device: Astra Tech Fixture ST