- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389245
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
April 22, 2020 updated by: Dentsply Sirona Implants and Consumables
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100050
- Capital Medical University School of Stomatology, Centre of Oral Implantation
-
Guangzhou, China, 510055
- Guanghua School of Stomatology, Sun Yat-Sen University
-
Nanjing, China, 210008
- Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm
|
OsseoSpeed™ TX implants of lengths 8-17 mm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marginal Bone Level Alteration
Time Frame: Measured at implant loading and at the 3-year follow-up after implant loading.
|
Marginal bone level 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 the 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
|
Measured at implant loading and at the 3-year follow-up after implant loading.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Stable Implants
Time Frame: Measured at the 3-year follow-up after implant loading.
|
Implant stability evaluated clinically/manually (recorded as stable yes/no).
|
Measured at the 3-year follow-up after implant loading.
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Time Frame: Measured at the 3-year follow-up after implant loading.
|
Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
Measured at the 3-year follow-up after implant loading.
|
Number of Survived Implants
Time Frame: Measured at the 3-year follow-up after implant loading.
|
Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
|
Measured at the 3-year follow-up after implant loading.
|
Presence of Plaque
Time Frame: Measured at the 3-year follow-up after implant loading.
|
Occurence of plaque around the study implant.
Presented as number of implants that show presence of plaque at time of the 3-year follow-up visit after implant loading.
|
Measured at the 3-year follow-up after implant loading.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Deng Feilong, MD, Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
July 6, 2011
First Submitted That Met QC Criteria
July 7, 2011
First Posted (Estimate)
July 8, 2011
Study Record Updates
Last Update Posted (Actual)
May 6, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHN-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Partially Edentulous Jaw
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Institut Straumann AGCompletedJaw, Edentulous, Partially | Jaw, EdentulousBelgium
-
Dentsply Sirona Implants and ConsumablesCompletedJaw, Edentulous, PartiallyUnited States, Germany
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompleted
-
NeodentActive, not recruiting
-
University of MichiganTerminatedJaw, Edentulous, PartiallyUnited States
-
Dentsply Sirona Implants and ConsumablesCompletedJaw, Edentulous, PartiallyUnited States, Germany
Clinical Trials on OsseoSpeed™ TX
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona Implants and ConsumablesCompletedJaw, Edentulous, PartiallyDenmark, Germany, Italy, Spain, Sweden, United Kingdom
-
Dentsply Sirona Implants and ConsumablesCompletedPartially Edentulous JawChina
-
Dentsply Sirona ImplantsCompletedPartial Edentulism in the Maxilla or in the MandibleUnited States, Belgium, Germany, Italy
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompletedPartial Edentulism | Edentulism NosSweden
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompleted
-
Dentsply Sirona Implants and ConsumablesCompletedOsteopenia | Jaw, Edentulous, Partially | Postmenopausal OsteoporosisBelgium, Germany, Sweden
-
Dentsply Sirona Implants and ConsumablesCompletedJaw, Edentulous, PartiallyUnited States, Germany