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OpenTrials
Completed

NCT Number: NCT05062863

An Observational Clinical Study of the T3 Dental Implant System

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Daniel Engler-Hamm, München, Germany

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About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either sex and at least 18 years of age.
  • 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.
  • Prior extracted sites or simultaneous extraction/implant placement.
  • Patients must be physically able to tolerate conventional surgical and restorative procedures.
  • Patients who provide a signed informed consent.
  • Patients who agree to be evaluated for each study visit.

Exclusion criteria

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

Treatment and study plan

T3 dental implant system

Device

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 outcomes

  1. Dental implant integration

    Time frame: 2 years

    The integration success measured by lack of mobility

Secondary outcomes

  1. Crestal Bone Loss

    Time frame: 2 years

    The measured changes in peri-implant crestal bone levels

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System

Acronym: Kashmir

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2021
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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