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(352) 733-0111

KASHMIR- 1804

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
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Objective

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.

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

Details

Full study title A Prospective, Observational Clinical study of the Safety, Effectiveness and Clinical Benefits of the T3 dental implant system ("KASHMIR")
Protocol number OCR40484
ClinicalTrials.gov ID NCT05062863

Eligibility

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.

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.