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

Jaw, Edentulous Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711022
• Other study ID #: YA-OSS-0008
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: July 4, 2014
• Start date: May 2005
• Est. completion date: March 2012

Study information

• Verified date: May 2014
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Device:
• ASTRA TECH Implant System, OsseoSpeed™, all dimensions.

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine	Uppsala
United States	The University of Chicago, MC-2108	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Sweden, 

References & Publications (3)

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. — View 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: 10.11 — View 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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 5-year follow-up	No