Study on OsseoSpeed™ TX Narrow 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:
NCT01389258
First received: July 6, 2011
Last updated: February 21, 2013
Last verified: February 2013
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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:
- Provision of informed consent
- Aged 20-75 years at enrollment
- History of edentulism in the study area of at least two months
- Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- 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
- 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, as deemed by the investigator
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per 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 weeks prior to enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389258
Contacts
| Contact: Rikard Pegelow | +46317763000 |
Locations
| China | |
| Tong Ji University, Oral Implants Department | Recruiting |
| Shanghai, China | |
| School of Stomatology Wuhan University | Recruiting |
| Wuhan, China, 430079 | |
| Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University | Recruiting |
| 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: | February 21, 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 19, 2013