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Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population | Clinical Trials | Clareo Health

COMPLETEDNA

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

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.

NCT01389258•Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of informed consent
•2. Aged 20-75 years at enrollment
•3. History of edentulism in the study area of at least two months
•4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
•5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
•6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
•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. Uncontrolled pathologic processes in the oral cavity
•3. Known or suspected current malignancy
•4. History of radiation therapy in the head and neck region
•5. History of chemotherapy within 5 years prior to surgery
•6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
•7. Uncontrolled diabetes mellitus
•8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
•9. Smoking more than 10 cigarettes per day
•10. Present alcohol and/or drug abuse
+3 more criteria

Locations (3)

Tong Ji University, Oral Implants Department

Shanghai, China

School of Stomatology Wuhan University

Wuhan, China

Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University

Xi'an, China

Key Dates

Start Date

June 1, 2011

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2016

Last Updated

October 15, 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 Implants in a Chinese Population

NCT01346683

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: October 15, 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.

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