Clinical trial NCT00711022: 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
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous
Keywords: Jaw, Edentulous (maxilla, with poor bone quality and quantity)
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant Survival Rate
timeFrame: At 5-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago, MC-2108
state: Illinois
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
Study officials:
affiliation: University of Chicago
name: Joseph A Toljanic, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.