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

March 24, 2022 updated by: ZimVie

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Regensburg, Bayern, Germany, 93053
        • Universitat Regensburg
    • Nordhein-Westfalen
      • Dusseldorf, Nordhein-Westfalen, Germany, 40225
        • Heinrich Heine Universität Düsseldorf
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsmedizin Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Benefit from the implant and restoration
  2. Provide a voluntarily signed Informed Consent
  3. Must be 18 years or older
  4. Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration
  5. The implantation site must have a functional antagonist to obtain full occlusion.
  6. Implants adjacent to planned site of implantation should have been in function for at least 1 year.
  7. 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.
  8. 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.
  9. The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.
  10. 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:

  1. Subjects mentally incompetent or unable to understand and provide an Informed Consent
  2. Smokers, alcoholics or drug abusers
  3. Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders
  4. Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate
  5. Bleeding disorders and/or anticoagulant therapy
  6. Pregnancy
  7. Known sensitivity or allergy to any of the implant materials
  8. Subjects with bruxism or clenching habits
  9. Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)
  10. Inadequate oral hygiene
  11. History of radiation at the site intended for study implant placement
  12. Subjects who have previously failed dental implants at the site intended for study implant placement
  13. Subjects participating in another clinical study
  14. Subjects who need other surgeries in a site adjacent to the study implant(s)
  15. Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tapered Screw-vent implants (TSV)
TSV implants to replace missing tooth/teeth
Device: Tapered screw-vent implants (TSV)
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.
Experimental: Trabecular Metal dental implants (TM)
TM dental implants to replace missing tooth/teeth
Device: Trabecular metal dental implants (TM)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: 3-18 weeks
Measure of Implant Stability Quotient immediately post implantation
3-18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone level change
Time Frame: 2 years
Measurement of bone level surrounding implant
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZimVie

Investigators

  • Principal Investigator: Wilfried Wagner, Universitatsbedizin Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU2011-08D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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