An Observational Clinical Study of the T3 Dental Implant System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-20

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Edentulous Jaw

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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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)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes