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

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.

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Key information

Conditions

Jaw, Edentulous Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine, Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Device

Primary outcomes

Implant Survival Rate

Time frame: At 5-year follow-up

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.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

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.

Important dates

Study start: 2005
Primary completion: 2012
Study completion: 2012
First posted: Jul 8, 2008
Registry last updated: Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed