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

NCT ID: NCT01389245

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-09-30

Brief 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.

Conditions

Partially Edentulous Jaw

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OsseoSpeed™ TX

OsseoSpeed™ TX implants of lengths 8-17 mm

Group Type: EXPERIMENTAL

OsseoSpeed™ TX

Intervention Type: DEVICE

OsseoSpeed™ TX implants of lengths 8-17 mm

Interventions

OsseoSpeed™ TX

OsseoSpeed™ TX implants of lengths 8-17 mm

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deng Feilong, MD

Role: PRINCIPAL_INVESTIGATOR

Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou

Locations

Capital Medical University School of Stomatology, Centre of Oral Implantation

Beijing, , China

Guanghua School of Stomatology, Sun Yat-Sen University

Guangzhou, , China

Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University

Nanjing, , China

Countries

China

Other Identifiers

CHN-0001

Identifier Type: -

Identifier Source: org_study_id