Overview

This trial is active, not recruiting.

Condition jaw, edentulous, partially
Treatments astra tech implant system, osseospeed™ 4.0 s (length: 6 mm), astra tech implant system, osseospeed™ implants (lengths: 11, 13, 15 mm)
Sponsor Dentsply Implants
Start date November 2009
End date November 2016
Trial size 100 participants
Trial identifier NCT01030523, YA-SHO-0002

Summary

The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) with bone substitution.

The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
astra tech implant system, osseospeed™ 4.0 s (length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
(Active Comparator)
ASTRA TECH Implants System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)
astra tech implant system, osseospeed™ implants (lengths: 11, 13, 15 mm)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm)

Primary Outcomes

Measure
Implant survival rate
time frame: On a regular basis during 5 years follow-up

Secondary Outcomes

Measure
Marginal bone level alterations
time frame: On a regular basis during 5 years follow-up
Condition of periimplant mucosa
time frame: On a regular basis during 5 years follow-up
Crown-to-implant ratio
time frame: On a regular basis during 5 years follow-up

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Provision of informed consent - Aged 20-75 years at enrolment - History of edentulism in the study area of at least four months - In need for 1-4 implants in either side of the posterior maxilla (premolar and molar region) - Neighboring tooth/teeth to the planned implant/s must have natural root(s) or implant supported restoration, with absence of pathology or excessive bone loss, as judged by the investigator - Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s - Deemed by the investigator to have a bone height between 5 and 7 mm and a bone width of a minimum of 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 bone 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, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration - Smoking more than 10 cigarettes/day - Bruxism - 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 - Simultaneous participation in another clinical study

Additional Information

Official title Short Implants - An Alternative to Bone Grafting?
Principal investigator Christoph Hämmerle, Prof. Dr. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Dentsply Implants.