CompletedNot Applicable

TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas

Germany120 participantsStarted 2013-03

Plain-language summary

Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Benefit from the implant and restoration
✓. Provide a voluntarily signed Informed Consent
✓. Must be 18 years or older
✓. Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration
✓. The implantation site must have a functional antagonist to obtain full occlusion.
✓. Implants adjacent to planned site of implantation should have been in function for at least 1 year.
✓. The site intended for implant placement should have healed for at least 4 months from the time of extraction or at least 6 months from any other bone augmentation procedures.
✓. The site intended for implant placement should have adequate bone volume to support an implant without the need for augmentation except for minor dehiscence (limited to a vertical height of 2mm), which can be augmented with autogenous bone chips to improve soft tissue attachment.

Exclusion criteria

✕. Subjects mentally incompetent or unable to understand and provide an Informed Consent
✕. Smokers, alcoholics or drug abusers
✕. Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders
✕. Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate
✕. Bleeding disorders and/or anticoagulant therapy
✕. Pregnancy
✕. Known sensitivity or allergy to any of the implant materials
✕. Subjects with bruxism or clenching habits

What they're measuring

Implant Stability

Timeframe: 3-18 weeks

Trial details

NCT IDNCT02158377

SponsorZimVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Partial Edentulism trials