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

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Prospective, Multicenter Study to Evaluate the Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants, in Patients With Totally Edentulous Maxillas and Poor Bone Quality and Quantity in an Immediate Loading Protocol.

Conditions
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Jaw, Edentulous

Intervention / Treatment
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* Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsseoSpeed<br> | Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. | At 5-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jaw, Edentulous (maxilla, with poor bone quality and quantity)