Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours

Dentsply

Status: Completed

Conditions: Jaw, Edentulous

Treatments: Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711022

YA-OSS-0008

Details and patient eligibility

About

The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.

Enrollment: 51 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Aged 20 years and over
• History of totally edentulous maxilla of at least three months
• Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla
• Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla
• Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system)
• Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.

Exclusion criteria

• Unlikely to be able to comply with study procedures, as judged by the investigator
• Uncontrolled pathologic processes in the oral cavity
• Known or suspected current malignancy
• History of radiation 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
• History of bone augmentation in the maxilla within 6 months prior to surgery
• Known pregnancy at time of enrolment
• Present alcohol and/or drug abuse
• Current use of tobacco or history of tobacco use within 6 months prior to surgery
• Need for interpreter

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

OsseoSpeed

Experimental group

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.