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.

NCT01346683•Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of informed consent
•2. Aged 20-75 years at enrolment
•3. 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.
•4. Neighboring tooth to the planned bridge must have natural root.
•5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
•6. Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
•7. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria

•1. Unlikely to be able to comply with study procedures, as judged by the investigator
•2. Earlier graft procedures in the study area
•3. Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
•4. Uncontrolled pathologic processes in the oral cavity
•5. Known or suspected current malignancy
•6. History of radiation therapy in the head and neck region
•7. History of chemotherapy within 5 years prior to surgery
•8. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
•9. Uncontrolled diabetes mellitus
•10. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
+6 more criteria

Locations (3)

Department of Prosthodontics, School of Stomatology, Beijing University

Beijing, China

Department of Prosthodontics & Dental Materials, Guanghua School of Stomatology, Sun Yat-Sen University

Guangzhou, China

Department of Prosthodontics, College of Stomatology, Shanghai Jiao Tong University

Shanghai, China

Key Dates

Start Date

February 1, 2011

Primary Completion Date

March 1, 2016

Completion Date

March 1, 2016

Last Updated

September 27, 2019

Enrollment

ACTUAL participants

Conditions

Partially Edentulous Jaw

Interventions

OsseoSpeed TX

DEVICE

Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population

NCT01389245

Partially Edentulous Jaw

View study

COMPLETEDNA

Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population

NCT01389258

Partially Edentulous Jaw

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions