Clinical trial NCT05062863: An Observational Clinical Study of the T3 Dental Implant System
Official title: A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Edentulous Jaw
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility 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.

Primary outcomes:
measure: Dental implant integration
timeFrame: 2 years
Secondary outcomes:
measure: Crestal Bone Loss
timeFrame: 2 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: München
country: Germany
facility: Dr. Daniel Engler-Hamm
Study officials:
affiliation: ZimVie
name: Hai Bo Wen, PhD
role: STUDY_DIRECTOR
References: