Back to resultsStudy on OsseoSpeed™ TX Narrow 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 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
Sites / Locations
- Tong Ji University, Oral Implants Department
- School of Stomatology Wuhan University
- Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OsseoSpeed™ TX
Arm Description
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Outcomes
Primary Outcome Measures
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Secondary Outcome Measures
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Marginal Bone Level Alteration
Marginal Bone Level (mm) 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.
Marginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).
Negative value = increased pocket depth.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Presence of Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Gingival Zenith Score
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.
Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Full Information
NCT ID
NCT01389258
First Posted
July 6, 2011
Last Updated
October 8, 2019
Sponsor
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT01389258
Brief Title
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (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 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.
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
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OsseoSpeed™ TX
Arm Type
Experimental
Arm Description
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™ TX
Intervention Description
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Primary Outcome Measure Information:
Title
Implant Survival
Description
Implant survival rate evaluated clinically and radiographically.
Time Frame
Measured at the 3-year follow-up visit after implant loading.
Secondary Outcome Measure Information:
Title
Implant Stability
Description
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time Frame
Measured at the 3-year follow-up visit after implant loading.
Title
Marginal Bone Level Alteration
Description
Marginal Bone Level (mm) 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.
Marginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Time Frame
Measured at the 3-year follow-up visit after implant loading.
Title
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Description
Change in pocket depth expressed in millimeters at time of the 3 years 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 implant loading and at the 3-year follow-up visit after loading.
Title
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
Description
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Time Frame
Measured at implant loading and at the 3-year follow-up visit after loading.
Title
Presence of Plaque
Description
Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Time Frame
Measured at the 3-year follow-up visit after implant loading.
Title
Gingival Zenith Score
Description
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.
Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Time Frame
Measured at implant loading and at the 3-year follow-up visit after 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Dehua, Prof
Organizational Affiliation
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tong Ji University, Oral Implants Department
City
Shanghai
Country
China
Facility Name
School of Stomatology Wuhan University
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
City
Xi'an
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
We'll reach out to this number within 24 hrs