Back to resultsStudy on OsseoSpeed™ TX Implants 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 enrolment
- History of edentulism in the posterior mandible, 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 enrolment 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
- Department of Prosthodontics, School of Stomatology, Beijing University
- Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
- Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong 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 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 at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Secondary Outcome Measures
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no)
Soft Tissue Status (PPD).
Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed.
A negative value = increased pocket depth.
Soft Tissue Status (BoP)
Soft tissue status measured by assessment of bleeding on probing (BoP).
Full Information
NCT ID
NCT01346683
First Posted
May 2, 2011
Last Updated
September 11, 2019
Sponsor
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT01346683
Brief Title
Study on OsseoSpeed™ TX Implants 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 Mandible. A 3-years Follow-up Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 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
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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible 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 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 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 at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Time Frame
Evaluated 3 years after implant loading
Secondary Outcome Measure Information:
Title
Implant Survival
Description
Implant survival rate evaluated clinically and radiographically.
Time Frame
From implant placement to the follow-up 36 months after loading.
Title
Implant Stability
Description
Implant stability evaluated clinically/manually (recorded as stable yes/no)
Time Frame
Measured from loading of implants to the follow-up 36 months after loading.
Title
Soft Tissue Status (PPD).
Description
Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed.
A negative value = increased pocket depth.
Time Frame
Measured from loading of implants to the follow-up 36 months after loading.
Title
Soft Tissue Status (BoP)
Description
Soft tissue status measured by assessment of bleeding on probing (BoP).
Time Frame
Measured from loading of implants to the follow-up 36 months 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 enrolment
History of edentulism in the posterior mandible, 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 enrolment 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
Yongsheng Zhou, Prof
Organizational Affiliation
Department of Prosthodontics, School of Stomatology, Beijing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Prosthodontics, School of Stomatology, Beijing University
City
Beijing
ZIP/Postal Code
100081
Country
China
Facility Name
Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
City
Guangzhou
ZIP/Postal Code
510055
Country
China
Facility Name
Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26790007
Citation
Zhou J, Huang Q, Wang X, Peng D, Li Y, Zhang L, Liu J, Zhang S, Zhao K, Jiang X, Zhou Y. Early loading of splinted implants in the posterior mandible: a prospective multicentre case series. J Clin Periodontol. 2016 Mar;43(3):298-304. doi: 10.1111/jcpe.12513. Epub 2016 Mar 1.
Results Reference
result
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Study on OsseoSpeed™ TX Implants in a Chinese Population
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