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

NCT ID: NCT01473355

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-10-31

Brief Summary

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.

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 narrow implants (diameter 3 mm) in lengths of 11-15 mm

Group Type: EXPERIMENTAL

OsseoSpeed™ TX

Intervention Type: DEVICE

OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Interventions

OsseoSpeed™ TX

OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Intervention Type: DEVICE

Eligibility 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

• 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

Ping Gong, Prof

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

School of Stomatology, JiLin University, Hospital of Stomatology

Changchun, , China

Sichuan University

Chengdu, , China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, , China

Countries

China

Other Identifiers

CHN-0003

Identifier Type: -

Identifier Source: org_study_id