N/A N=51 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00711022 ↗

Enrolled (actual)

Serious AEs

9.8%

Results posted

May 2014

Primary outcome: Primary: Implant Survival Rate — 93.10 percentage of implants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ASTRA TECH Implant System, OsseoSpeed™, all dimensions. (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Dentsply Sirona Implants and Consumables
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Implant Survival Rate	93.10	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00711022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.