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

Not Applicable

Completed

• Conditions: Jaw, Edentulous
• Interventions: Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

• Registration Number: NCT00711022
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2014-03-12
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-05
• Results First Posted: 2014-05-13
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OsseoSpeed	ASTRA TECH Implant System, OsseoSpeed™, all dimensions.	-

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	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.

Trial Locations

Locations (2)

The University of Chicago, MC-2108; 🇺🇸 Chicago, Illinois, United States

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