Study on OsseoSpeed™ TX Short Implants in a Chinese Population

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01346696
First received: May 2, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to investigate the clinical efficacy of Osseospeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.


Condition Intervention
Partially Edentulous Jaw
Device: OsseoSpeed™ TX implants

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Marginal bone level alteration [ Time Frame: 12 months after implant loading ] [ Designated as safety issue: No ]
    Marginal Bone Level will be determined from radiographs and expressed as the 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. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).


Secondary Outcome Measures:
  • Implant stability [ Time Frame: At implant placement, loading, 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
    Implant stability will be evaluated clinically/manually (recorded as stable yes/no).

  • Marginal bone level alteration [ Time Frame: At 24 and 36 months follow-up ] [ Designated as safety issue: No ]
    Marginal Bone Level will be determined from radiographs and expressed as the 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. Marginal Bone Level expressed in millimeters at the 24 and 36 months follow-up visits will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

  • Condition of the periimplant mucosa [ Time Frame: At loading and 1, 6, 12, 24 and 36 months follwow-up ] [ Designated as safety issue: No ]
    Condition of the periimplant mucosa will be measured by assessment of bleeding on probing and measurement of probing pocket depth.

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

  • Crown-to-implant ratio [ Time Frame: 12 months after implant loading ] [ Designated as safety issue: No ]
    Crown height will be measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio will be calculated from radiographs

  • Implant survival [ Time Frame: From implant placement to 36 months after loading. ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated clinically and radiographically.


Estimated Enrollment: 45
Study Start Date: February 2011
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OsseoSpeed™ TX implants
    OsseoSpeed™ TX implants of length 6 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. Female and male aged 20-75 years at enrolment
  3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
  4. History of edentulism in the study area of at least four months
  5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
  6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
  7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
  8. 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. Uncontrolled pathologic processes in the oral cavity
  4. Known or suspected current malignancy
  5. History of radiation therapy in the head and neck region
  6. History of chemotherapy within 5 years prior to surgery
  7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
  8. Uncontrolled diabetes mellitus
  9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  10. Smoking more than 10 cigarettes/day
  11. Present alcohol and/or drug abuse
  12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  13. Previous enrolment in the present study
  14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
  15. Subjects that are unable to give informed consent
  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: NCT01346696

Locations
China
Department of Periodontology, School of Stomatology, Peking University
Beijing, China, 100081
Second Dental and Periodontal Center, School of Stomatology, Peking University
Beijing, China
Department of Implantology, School of Stomatology, Peking University
Beijing, China
Sponsors and Collaborators
Dentsply Implants
Investigators
Principal Investigator: Huan Xin Meng, Prof Department of Periodontology, School of Stomatology, Beijing University
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT01346696     History of Changes
Other Study ID Numbers: CHN-0005
Study First Received: May 2, 2011
Last Updated: January 9, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014