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An Observational Clinical Study of the T3 Dental Implant System (Kashmir)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05062863
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
ZimVie

Brief Summary:
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Condition or disease Intervention/treatment
Edentulous Jaw Device: T3 dental implant system

Detailed Description:

This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.

The main objectives of this study will be:

  1. The integration success of the dental implant (as measured by mobility)
  2. The measured changes in peri-implant crestal bone levels for each implant
  3. Confirmation of clinical benefits

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: T3 dental implant system
    This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).
    Other Names:
    • T3 platform switched certain parallel walled (BOPS)
    • T3 non-platform switched certain parallel walled (BOSS)
    • T3 with DCD platform switched certain parallel walled (BNPS)
    • T3 with DCD non-platform switched certain parallel walled (BNSS)


Primary Outcome Measures :
  1. Dental implant integration [ Time Frame: 2 years ]
    The integration success measured by lack of mobility


Secondary Outcome Measures :
  1. Crestal Bone Loss [ Time Frame: 2 years ]
    The measured changes in peri-implant crestal bone levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.
Criteria

Inclusion Criteria:

  1. Patients of either sex and at least 18 years of age.
  2. Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
  3. Prior extracted sites or simultaneous extraction/implant placement.
  4. Patients must be physically able to tolerate conventional surgical and restorative procedures.
  5. Patients who provide a signed informed consent.
  6. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

  1. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
  2. Patients who have previously failed dental implants at the site intended for study implant placement.
  3. Patients with active HIV or Hepatitis infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062863


Contacts
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Contact: Cristina Matthews 5617766722 cristina.matthews@zimvie.com
Contact: Hai Bo Wen, PhD 561-776-6996 haibo.wen@zimvie.com

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Karin Schey, DDS, MS    352-273-8369    KSchey@dental.ufl.edu   
Contact: Abigale Bell    (352) 273-8369    ABell@dental.ufl.edu   
United States, New Jersey
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Wellington Tsai, DMD, MS    732-776-4212    Dr.Tsai@hamiltonsquaredental.com   
Germany
Dr. Daniel Engler-Hamm Recruiting
München, Germany, 80333
Contact: Daniel Engler-Hamm, Dr. Med Dent    0172 494 1112    englerhamm@gmail.com   
Sponsors and Collaborators
ZimVie
Investigators
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Study Director: Hai Bo Wen, PhD ZimVie
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Responsible Party: ZimVie
ClinicalTrials.gov Identifier: NCT05062863    
Other Study ID Numbers: 1804
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Jaw, Edentulous
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases