CompletedNot Applicable

A Clinical Study of the T3 Short Dental Implant System

United States, Italy, Spain106 participantsStarted 2019-10-01

Plain-language summary

This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 partial edentulism in the posterior mandible or maxilla.
✓. Prior extracted sites (at least 4 months after extraction) preferred; immediate extractions allowed
✓. Splinting to a natural tooth is allowed for the short length (test) implants
✓. Intact buccal table as verified by CBCT or during surgery. If absent, patient should be excluded from enrollment in the study.
✓. Presence of opposing dentition (antagonist) that will allow for functional occlusion.
✓. The site intended for implant placement should have a minimum amount of keratinized gingiva of 2mm and a sufficient vertical bone height (8 - 10 mm in the maxilla; 10mm in the mandible); a short implant (as determined by randomization) will be placed without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips to improve soft tissue attachment. If site was randomized to long length implant (control) (with a minimum of 8mm vertical bone height in the maxilla or less than 10 mm in the mandible) it will have simultaneous augmentation procedure (sinus elevation in the maxilla; vertical ridge augmentation in the mandible).
✓. The site intended for implant placement should have approximately 1.5mm buccal-lingual distance on each side in order to allow for wide platform implant (5 and 6mm diameter).

✕. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
✕. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
✕. Patients with active infection or severe inflammation in the areas intended for treatment.
✕. Patients with a \> 10 cigarette per day smoking habit.
✕. Patients with a history of therapeutic radiation to the head or jaw.
✕. Patients receiving other dental treatment(s) during the study that could have a negative impact on the healing phase of the study treatment sites.
✕. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
✕. Patients with evidence of severe parafunctional habits such as bruxing or clenching.

Crestal Bone regression

Timeframe: 4 years

NCT IDNCT04237545

SponsorZimVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 partial edentulism in the posterior mandible or maxilla.
✓. Prior extracted sites (at least 4 months after extraction) preferred; immediate extractions allowed
✓. Splinting to a natural tooth is allowed for the short length (test) implants
✓. Intact buccal table as verified by CBCT or during surgery. If absent, patient should be excluded from enrollment in the study.
✓. Presence of opposing dentition (antagonist) that will allow for functional occlusion.
✓. The site intended for implant placement should have a minimum amount of keratinized gingiva of 2mm and a sufficient vertical bone height (8 - 10 mm in the maxilla; 10mm in the mandible); a short implant (as determined by randomization) will be placed without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips to improve soft tissue attachment. If site was randomized to long length implant (control) (with a minimum of 8mm vertical bone height in the maxilla or less than 10 mm in the mandible) it will have simultaneous augmentation procedure (sinus elevation in the maxilla; vertical ridge augmentation in the mandible).
✓. The site intended for implant placement should have approximately 1.5mm buccal-lingual distance on each side in order to allow for wide platform implant (5 and 6mm diameter).

✕. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
✕. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
✕. Patients with active infection or severe inflammation in the areas intended for treatment.
✕. Patients with a \> 10 cigarette per day smoking habit.
✕. Patients with a history of therapeutic radiation to the head or jaw.
✕. Patients receiving other dental treatment(s) during the study that could have a negative impact on the healing phase of the study treatment sites.
✕. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
✕. Patients with evidence of severe parafunctional habits such as bruxing or clenching.