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

Z

ZimVie

Status

Active, not recruiting

Conditions

Edentulous Jaw

Treatments

Device: T3 dental implant system

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

4

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Central trial contact

Hai Bo Wen, PhD; Cristina Matthews

Data sourced from clinicaltrials.gov

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