Study on OsseoSpeed™ TX Implants in the Upper Jaw 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 Maxilla. A 3-years Follow-up Study.
1 other identifier
interventional
42
1 country
3
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.
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 Jun 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
May 6, 2020
CompletedMay 6, 2020
April 1, 2020
4.1 years
July 6, 2011
April 22, 2020
April 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Measured at implant loading and at the 3-year follow-up after implant loading.
Secondary Outcomes (4)
Number of Stable Implants
Measured at the 3-year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Measured at the 3-year follow-up after implant loading.
Number of Survived Implants
Measured at the 3-year follow-up after implant loading.
Presence of Plaque
Measured at the 3-year follow-up after implant 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 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
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 enrollment 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)
Capital Medical University School of Stomatology, Centre of Oral Implantation
Beijing, 100050, China
Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, 510055, China
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Nanjing, 210008, China
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
Deng Feilong, MD
Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
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
July 6, 2011
First Posted
July 8, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2015
Study Completion
September 1, 2017
Last Updated
May 6, 2020
Results First Posted
May 6, 2020
Record last verified: 2020-04