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Completed

NCT Number: NCT02158377

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

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

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Key information

Conditions

Partial Edentulism Stomatognathic Diseases Tooth Disease Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Regensburg, Regensburg, Bavaria, Germany

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About this study

This is a randomized, controlled, multicenter study to assess and compare implant stability of Trabecular Metal (TM) dental implants and Tapered Screw-Vent (TSV) implants during the early stages of healing i.e. 21 +/- 2 days and 42+/- 2 days, as well as their short term clinical outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

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.
  • The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.
  • The site intended for implant placement should have vertical bone volume to extend at least 2.0mm apical to the implant after implant placement.

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
  • Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)
  • Inadequate oral hygiene
  • History of radiation at the site intended for study implant placement
  • Subjects who have previously failed dental implants at the site intended for study implant placement
  • Subjects participating in another clinical study
  • Subjects who need other surgeries in a site adjacent to the study implant(s)
  • Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement

Treatment and study plan

Trabecular metal dental implants (TM)

Device

Patients receive TM dental implants in this arm. The early stability is measured and compared to the stability of the TSV implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.

Tapered screw-vent implants (TSV)

Device

Patients receive TSV dental implants in this arm. The early stability is measured and compared to the stability of the TM implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.

Primary outcomes

  1. Implant Stability

    Time frame: 3-18 weeks

    Measure of Implant Stability Quotient immediately post implantation

Secondary outcomes

  1. Marginal bone level change

    Time frame: 2 years

    Measurement of bone level surrounding implant

Sponsors and collaborators

Lead sponsor

ZimVie

Industry

Registry information

Official study title

A Randomized Controlled Multicenter Study of Trabecular Metal Dental Implants vs.Tapered Screw-Vent Dental Implants Loaded Early vs. Conventionally in the Maxilla and Mandible.

Acronym: TMEL

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Jun 6, 2014
Registry last updated
Mar 29, 2022

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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