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

• ClinicalTrials.gov Identifier: NCT00711022
• Recruitment Status: Completed
• First Posted: July 8, 2008
• Results First Posted: May 13, 2014
• Last Update Posted: July 16, 2014
• Sponsor: Dentsply Sirona Implants
• Information provided by (Responsible Party): Dentsply Sirona Implants

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.

Condition or disease	Intervention/treatment	Phase
Jaw, Edentulous	Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2005
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: OsseoSpeed	Device: ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

The University of Chicago, MC-2108

Chicago, Illinois, United States, 60637

Sweden

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

Uppsala, Sweden, SE-751 85

Sponsors and Collaborators

Dentsply Sirona Implants

Investigators

• Principal Investigator: Joseph A Toljanic, Prof.; University of Chicago

More Information

Publications of Results:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Erkapers M, Segerström 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.

• Responsible Party: Dentsply Sirona Implants
• ClinicalTrials.gov Identifier: NCT00711022
• Other Study ID Numbers: YA-OSS-0008
• First Posted: July 8, 2008
• Results First Posted: May 13, 2014
• Last Update Posted: July 16, 2014
• Last Verified: May 2014

Keywords provided by Dentsply Sirona Implants:

Jaw, Edentulous (maxilla, with poor bone quality and quantity)

Additional relevant MeSH terms:

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