Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population

• Register: ClinicalTrials.gov
• Last refreshed on: 25 February 2013
• Main ID: NCT01473355
• Date of registration: 15/11/2011
• Primary sponsor: Dentsply Implants
• Public title: Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
• Scientific 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.
• Date of first enrolment: October 2011
• Target sample size: 45
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01473355
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Ping Gong, Prof
• Affiliation: Sichuan University

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Partially Edentulous Jaw

Intervention(s)

Device: OsseoSpeed™ TX

Primary Outcome(s)

Marginal bone level alteration [Time Frame: At 12 months after implant loading]

Secondary Outcome(s)

Implant stability [Time Frame: At 36 months after implant loading]

Implant stability [Time Frame: At implant loading (6-8 weeks after implant placement)]

Implant survival [Time Frame: At 36 months after implant loading]

Secondary ID(s)

CHN-0003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors