Overview

This trial is active, not recruiting.

Condition jaw, edentulous, partially
Treatments osseospeed™
Sponsor Dentsply Implants
Start date November 2007
End date May 2016
Trial size 97 participants
Trial identifier NCT00545818, YA-SHO-0001

Summary

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
osseospeed™
OsseoSpeed™ implant, length: 6 mm
(Active Comparator)
osseospeed™
OsseoSpeed™ implant, length: 11 mm

Primary Outcomes

Measure
Radiological assessments of marginal bone level alteration
time frame: On a regular basis during 5 years follow-up

Secondary Outcomes

Measure
Implant survival (on implant and patient level) Condition of periimplant mucosa Overall safety
time frame: On a regular basis during 5 years follow-up

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - Provision of informed consent - Aged 20-70 years at enrolment - History of edentulism in the study area of at least four months - Neighboring tooth/teeth to the planned bridge must have natural root(s) - Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge. - Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm - Deemed by the investigator as likely to present an initially stable implant situation Exclusion Criteria: - Unlikely to be able to comply with study procedures, as judged by the investigator - Earlier graft procedures in the study area - Uncontrolled pathologic processes in the oral cavity - Known or suspected current malignancy - History of radiation therapy in the head and neck region - History of chemotherapy within 5 years prior to surgery - Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration - Uncontrolled diabetes mellitus - Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration - Smoking more than 10 cigarettes/day - Present alcohol and/or drug abuse - Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) - Previous enrolment in the present study. - Severe non-compliance to protocol as judged by the investigator and/or Astra Tech - Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months

Additional Information

Official title An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dentsply Implants.