Study on OsseoSpeed™ TX Implants in a Chinese Population
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: May 2, 2011
Last updated: January 9, 2014
Last verified: January 2014
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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible 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 Mandible. 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 bleeding on probing and measurement of probing pocket depth.
- 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.
- 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:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2016 (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 enrolment
- History of edentulism in the posterior mandible, 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 enrolment 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346683
|Department of Prosthodontics, School of Stomatology, Beijing University
|Beijing, China, 100081 |
|Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
|Guangzhou, China, 510055 |
|Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University
|Shanghai, China, 200011 |
||Yongsheng Zhou, Prof
||Department of Prosthodontics, School of Stomatology, Beijing University
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2011
||January 9, 2014
||China: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 22, 2014