Back to resultsStudy on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
Primary Purpose
Partially Edentulous Jaw
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OsseoSpeed™ TX
Sponsored by
About this trial
This is an interventional treatment trial for Partially Edentulous Jaw
Eligibility 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
Sites / Locations
- Capital Medical University School of Stomatology, Centre of Oral Implantation
- Guanghua School of Stomatology, Sun Yat-Sen University
- Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OsseoSpeed™ TX
Arm Description
OsseoSpeed™ TX implants of lengths 8-17 mm
Outcomes
Primary Outcome Measures
Marginal Bone Level Alteration
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).
Secondary Outcome Measures
Number of Stable Implants
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
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.
Number of Survived Implants
Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
Presence of Plaque
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.
Full Information
NCT ID
NCT01389245
First Posted
July 6, 2011
Last Updated
April 22, 2020
Sponsor
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT01389245
Brief Title
Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Jaw
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OsseoSpeed™ TX
Arm Type
Experimental
Arm Description
OsseoSpeed™ TX implants of lengths 8-17 mm
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™ TX
Intervention Description
OsseoSpeed™ TX implants of lengths 8-17 mm
Primary Outcome Measure Information:
Title
Marginal Bone Level Alteration
Description
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).
Time Frame
Measured at implant loading and at the 3-year follow-up after implant loading.
Secondary Outcome Measure Information:
Title
Number of Stable Implants
Description
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time Frame
Measured at the 3-year follow-up after implant loading.
Title
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Description
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.
Time Frame
Measured at the 3-year follow-up after implant loading.
Title
Number of Survived Implants
Description
Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.
Time Frame
Measured at the 3-year follow-up after implant loading.
Title
Presence of Plaque
Description
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.
Time Frame
Measured at the 3-year follow-up after implant loading.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deng Feilong, MD
Organizational Affiliation
Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Medical University School of Stomatology, Centre of Oral Implantation
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Guanghua School of Stomatology, Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510055
Country
China
Facility Name
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
City
Nanjing
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
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Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population
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