Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
This study is currently recruiting participants.
Verified February 2013 by Dentsply Implants
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01389245
First received: July 6, 2011
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
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.
| 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 the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study. |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Marginal bone level alteration [ Time Frame: At 12 months after implant loading ] [ Designated as safety issue: No ]Marginal bone level will be determined from radiographs and expressed as the distance 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 the12 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 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: | 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 implants of lengths 8-17 mm
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389245
Contacts
| Contact: Rikard Pegelow | +46313763500 |
Locations
| China | |
| Capital Medical University School of Stomatology, Centre of Oral Implantation | Recruiting |
| Beijing, China, 100050 | |
| Guanghua School of Stomatology, Sun Yat-Sen University | Recruiting |
| Guangzhou, China, 510055 | |
| Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University | Recruiting |
| Nanjing City, China, 210008 | |
Sponsors and Collaborators
Dentsply Implants
Investigators
| Principal Investigator: | Deng Feilong, MD | Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou |
More Information
No publications provided
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT01389245 History of Changes |
| Other Study ID Numbers: | CHN-0001 |
| Study First Received: | July 6, 2011 |
| Last Updated: | February 22, 2013 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Jaw, Edentulous Mouth, Edentulous Jaw Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on May 23, 2013