Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

Dentsply

Status: Completed

Conditions: Jaw, Edentulous, Partially

Treatments: Device: ASTRA TECH Implant System, OsseoSpeed™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00710944

YA-OSS-0006

Details and patient eligibility

About

The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• 18 years of age and over
• A minimum of 20 stable intra occlusal contacts after planned restoration
• In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25

Exclusion criteria

• Untreated rampant caries and uncontrolled periodontal disease
• Use of smoking tobacco at time of inclusion
• History of pre-surgical bone augmentation, within 4 months, in the planned implant area
• History of extraction without augmentation, within 3 months in the planned implant area
• Absence of opposing dentition
• Absence of adjacent (mesial and/or distal) natural tooth
• Uncontrolled diabetes
• Known pregnancy at time of inclusion
• Present alcohol or drug abuse
• Any 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
• Unable or unwilling to return for follow-up visits for a period of 5 years
• Unrealistic esthetical demands
• Unlikely to be able to comply with study procedures according to Investigators judgment
• Already included in this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Extraction Sockets

Experimental group

Description:

Immediate loading in extraction sockets.

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™

Healed Ridges

Experimental group

Description:

Immediate loading in healed ridges.

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™

Grafted Sites

Experimental group

Description:

Immediate loading of implants placed in grafted sites (four months healing after grafting).

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™