Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
Verified January 2014 by Dentsply Implants
Information provided by (Responsible Party):
First received: July 6, 2011
Last updated: January 9, 2014
Last verified: January 2014
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.
Partially Edentulous Jaw
Device: OsseoSpeed™ TX
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
Primary Outcome Measures:
Secondary Outcome Measures:
- Implant stability [ Time Frame: At implant placement, loading and at 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)
- Soft tissue status [ Time Frame: At loading and at 6, 12, 24 and 36 months follow-up. ] [ Designated as safety issue: No ]
Soft tissue status will be measured by assessment of bleading on probing and measurement of probing pocket depth.
- Implant survival [ Time Frame: From implant placement to 36 months after loading. ] [ Designated as safety issue: No ]
Implant survival rate will be evaluated by clinically and radiographically.
- Plaque [ Time Frame: At 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:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2017 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||20 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Provision of informed consent
- Aged 20-75 years at enrollment
- 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.
- Neighboring tooth to the planned bridge must have natural root.
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
- Deemed by the investigator as likely to present an initially stable implant situation
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrollment in the present study.
- Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months.
- Subjects that are unable to give informed consent
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: NCT01389245
|Contact: Robert Corbé
|Capital Medical University School of Stomatology, Centre of Oral Implantation
|Beijing, China, 100050 |
|Guanghua School of Stomatology, Sun Yat-Sen University
|Guangzhou, China, 510055 |
|Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
|Nanjing City, China, 210008 |
||Deng Feilong, MD
||Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 6, 2011
||January 9, 2014
||China: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014