Overview

This trial is active, not recruiting.

Condition partially edentulous jaw
Treatment osseospeed™ tx
Sponsor Dentsply Implants
Start date June 2011
End date October 2017
Trial size 42 participants
Trial identifier NCT01389245, CHN-0001

Summary

The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the posterior maxilla is a safe and predictable procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
OsseoSpeed™ TX implants of lengths 8-17 mm
osseospeed™ tx
OsseoSpeed™ TX implants of lengths 8-17 mm

Primary Outcomes

Measure
Marginal bone level alteration
time frame: At 12 months after implant loading

Secondary Outcomes

Measure
Implant stability
time frame: At implant placement, loading and at 6, 12, 24 and 36 months follow-up.
Soft tissue status
time frame: At loading and at 6, 12, 24 and 36 months follow-up.
Implant survival
time frame: From implant placement to 36 months after loading.
Plaque
time frame: At 6, 12, 24 and 36 months follow-up.

Eligibility Criteria

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

Inclusion criteria: 1. Provision of informed consent 2. Aged 20-75 years at enrollment 3. History of edentulism in the posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid. 4. Neighboring tooth to the planned bridge must have natural root. 5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge. 6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm. 7. Deemed by the investigator as likely to present an initially stable implant situation Exclusion criteria: 1. Unlikely to be able to comply with study procedures, as judged by the investigator 2. Earlier graft procedures in the study area 3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area. 4. Uncontrolled pathologic processes in the oral cavity 5. Known or suspected current malignancy 6. History of radiation therapy in the head and neck region 7. History of chemotherapy within 5 years prior to surgery 8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration 9. Uncontrolled diabetes mellitus 10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 11. Smoking more than 10 cigarettes/day 12. Present alcohol and/or drug abuse 13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 14. Previous enrollment in the present study. 15. Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months. 16. Subjects that are unable to give informed consent

Additional Information

Official title An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
Principal investigator Deng Feilong, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dentsply Implants.