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

October 7, 2019 updated by: Dentsply Sirona Implants and Consumables

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. A 3-years Follow-up Study.

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 mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changchun, China
        • School of Stomatology, JiLin University, Hospital of Stomatology
      • Chengdu, China, 610041
        • Sichuan University
      • Hangzhou, China, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Provision of informed consent
  2. Aged 20-75 years at enrolment
  3. History of edentulism in the study area of at least two months
  4. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  5. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  6. 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
  11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  12. Previous enrollment in the present study
  13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
Device: OsseoSpeed™ TX
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Survived Implants
Time Frame: Measured at the 3 year follow-up after implant loading.
Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function
Measured at the 3 year follow-up after implant loading.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marginal Bone Level Alteration
Time Frame: Measured at the 3 year follow-up after implant loading.
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 the 3 year follow-up after implant loading.
Number of Stable Implants
Time Frame: Measured at the 3 year follow-up after implant loading.
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Time Frame: Measured at the 3 year follow-up after implant loading.

Condition of the periimplant mucosa by assessment of probing pocket depth (PPD).

Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).

Negative value = increased pocket depth.
Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
Time Frame: Measured at the 3 year follow-up after implant loading.
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Measured at the 3 year follow-up after implant loading.
Presence of Plaque
Time Frame: Measured at the 3 year follow-up after implant loading.
Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.
Measured at the 3 year follow-up after implant loading.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dentsply Sirona Implants and Consumables

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ping Gong, Prof, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHN-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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