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Trial record 9 of 301 for:    Recruiting, Not yet recruiting, Available Studies | "Tooth Diseases"

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

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ClinicalTrials.gov Identifier: NCT02158377
Recruitment Status : Recruiting
First Posted : June 6, 2014
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment Phase
Partial Edentulism Tooth Disease Device: Trabecular metal dental implants (TM) Device: Tapered screw-vent implants (TSV) Phase 4

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  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : March 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

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.




Primary Outcome Measures :
  1. Implant Stability [ Time Frame: 3-18 weeks ]

Secondary Outcome Measures :
  1. Marginal bone level change [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158377


Contacts
Contact: Cristina Matthews 561-776-6722 cristina.matthews@zimmerbiomet.com
Contact: Hai Bo Wen, PhD 5617776-6996 haibo.wen@zimmerbiomet.com

Locations
Germany
Universitat Regensburg Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Castro Jose, Dr    +49 941 9446326    jose.castro@ukr.de   
Contact: Carmen Hunglinger    +49 941 9446307    carmen.hunglinger@klinik.uni-regensburg.de   
Principal Investigator: Torsten E Reichert, Prof.Dr.Dr         
Heinrich Heine Universitat Dusseldorf Recruiting
Dusseldorf, Nordhein-Westfalen, Germany, 40225
Contact: Martens Daniel, Dr    +49 211 81 18 155    daniel.martens@med.uni-dusseldorf.de   
Contact: Katharina Kurzinski    +49 211 811 8141    katharina.kurzinski@med.uni-dusseldorf.de   
Principal Investigator: Jurgen Becker, Prof.Dr.         
Universitatsmedizin Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Bilal Al-Nawas, Dr med.dent.    +49 6131 17 7334    bilal.al-nawas@unimedizin-mainz.de   
Contact: Silke Otto         
Principal Investigator: Wilfried Wagner, Dr.med.dent.         
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Wilfried Wagner Universitatsbedizin Mainz

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02158377     History of Changes
Other Study ID Numbers: CSU2011-08D
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Dental implants
Trabecular Metal dental implants
TSV dental implants
Zimmer Dental
Implant stability
Implant stability quotient (ISQ)
Resonance Frequency Analysis (RFA)

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases