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

Primary Purpose

Jaw, Edentulous

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous focused on measuring Jaw, Edentulous (maxilla, with poor bone quality and quantity)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Chicago, MC-2108
  • Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OsseoSpeed

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
July 4, 2014
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00711022
Brief Title
Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous
Keywords
Jaw, Edentulous (maxilla, with poor bone quality and quantity)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OsseoSpeed
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Primary Outcome Measure Information:
Title
Implant Survival Rate
Description
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.
Time Frame
At 5-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 Present alcohol and/or drug abuse Current use of tobacco or history of tobacco use within 6 months prior to surgery Need for interpreter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Toljanic, Prof.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago, MC-2108
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19587876
Citation
Toljanic JA, Baer RA, Ekstrand K, Thor A. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial. Int J Oral Maxillofac Implants. 2009 May-Jun;24(3):518-26.
Results Reference
result
PubMed Identifier
21483889
Citation
Erkapers M, Ekstrand K, Baer RA, Toljanic JA, Thor A. Patient satisfaction following dental implant treatment with immediate loading in the edentulous atrophic maxilla. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):356-64.
Results Reference
result
PubMed Identifier
24818203
Citation
Thor A, Ekstrand K, Baer RA, Toljanic JA. Three-year follow-up of immediately loaded implants in the edentulous atrophic maxilla: a study in patients with poor bone quantity and quality. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):642-9. doi: 10.11607/jomi.3163.
Results Reference
result
PubMed Identifier
29126426
Citation
Erkapers M, Segerstrom S, Ekstrand K, Baer RA, Toljanic JA, Thor A. The influence of immediately loaded implant treatment in the atrophic edentulous maxilla on oral health related quality of life of edentulous patients: 3-year results of a prospective study. Head Face Med. 2017 Nov 10;13(1):21. doi: 10.1186/s13005-017-0154-0.
Results Reference
derived

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

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