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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01389258
First received: July 6, 2011
Last updated: June 26, 2014
Last verified: January 2014
  Purpose

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 maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.


Condition Intervention
Partially Edentulous Jaw
Device: OsseoSpeed™ TX

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant survival [ Time Frame: At 12 months after implant loading ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated clinically and radiographically.


Secondary Outcome Measures:
  • Marginal bone level alteration [ Time Frame: At implant placement, loading and at 1, 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Marginal Bone Level (mm) will be determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.

  • Soft tissue status [ Time Frame: At loading and at 1, 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Soft tissue status will be measured by assessment of bleeding and probing and measurement of probing pocket depth.

  • Implant survival [ Time Frame: At 24 and 36 months follow-up ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated clinically and radiographically.

  • Gingival zenith score [ Time Frame: At loading and at 1, 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Gingival zenith score will be measured from the gingival zenith to the incisal edge of the prosthetic crown.

  • Plaque [ Time Frame: At 1, 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Occurrence of plaque around the study implant will be recorded.


Estimated Enrollment: 45
Study Start Date: June 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OsseoSpeed™ TX
    OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Provision of informed consent
  2. Aged 20-75 years at enrollment
  3. History of edentulism in the study area of at least two months
  4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
  5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389258

Locations
China
Tong Ji University, Oral Implants Department
Shanghai, China
School of Stomatology Wuhan University
Wuhan, China, 430079
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Xi'an, China, 710032
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Li Dehua, Prof Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT01389258     History of Changes
Other Study ID Numbers: CHN-0006
Study First Received: July 6, 2011
Last Updated: June 26, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Mouth Diseases
Mouth, Edentulous
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 20, 2014