This trial is active, not recruiting.

Condition partially edentulous jaw
Treatment osseospeed™ tx
Sponsor Dentsply Sirona Implants
Start date October 2011
End date March 2017
Trial size 45 participants
Trial identifier NCT01473355, CHN-0003


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
osseospeed™ tx
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Primary Outcomes

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

Secondary Outcomes

Implant stability
time frame: At implant loading (6-8 weeks after implant placement)
Implant stability
time frame: At 36 months after implant loading
Implant survival
time frame: At 36 months after implant loading

Eligibility Criteria

All participants from 20 years up to 75 years old.

Inclusion criteria: 1. Provision of informed consent 2. Aged 20-75 years at enrolment 3. History of edentulism in the study area of at least two months 4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns 5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant 6. 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. Uncontrolled pathologic processes in the oral cavity 3. Known or suspected current malignancy 4. History of radiation therapy in the head and neck region 5. History of chemotherapy within 5 years prior to surgery 6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator 7. Uncontrolled diabetes mellitus 8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration 9. Smoking more than 10 cigarettes per day 10. Present alcohol and/or drug abuse 11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 12. Previous enrollment in the present study 13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Additional Information

Official title An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. A 3-years Follow-up Study.
Principal investigator Ping Gong, Prof
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Dentsply Sirona Implants.