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.

Dentsply Sirona Implants and Consumables2 sites in 2 countries51 target enrollmentMay 2005

ConditionsJaw, Edentulous

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaw, Edentulous
Sponsor: Dentsply Sirona Implants and Consumables
Enrollment: 51
Locations: 2
Primary Endpoint: Implant Survival Rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

March 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dentsply Sirona Implants and Consumables

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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.