Study on OsseoSpeed™ TX Implants in a Chinese Population
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.
1 other identifier
interventional
45
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
May 10, 2019
CompletedSeptember 27, 2019
September 1, 2019
5.1 years
May 2, 2011
February 11, 2019
September 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Evaluated 3 years after implant loading
Secondary Outcomes (4)
Implant Survival
From implant placement to the follow-up 36 months after loading.
Implant Stability
Measured from loading of implants to the follow-up 36 months after loading.
Soft Tissue Status (PPD).
Measured from loading of implants to the follow-up 36 months after loading.
Soft Tissue Status (BoP)
Measured from loading of implants to the follow-up 36 months after loading.
Study Arms (1)
OsseoSpeed TX
EXPERIMENTALOsseoSpeed TX implants of lengths 8-17 mm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Prosthodontics, School of Stomatology, Beijing University
Beijing, 100081, China
Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, 510055, China
Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University
Shanghai, 200011, China
Related Publications (1)
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.
PMID: 26790007RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager Global Clinical Research
- Organization
- Dentsply Sirona Implants, Mölndal, SWEDEN
Study Officials
- PRINCIPAL INVESTIGATOR
Yongsheng Zhou, Prof
Department of Prosthodontics, School of Stomatology, Beijing University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 3, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 27, 2019
Results First Posted
May 10, 2019
Record last verified: 2019-09