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

Primary Purpose

Partial Edentulism, Tooth Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Trabecular metal dental implants (TM)

Tapered screw-vent implants (TSV)

About this trial

This is an interventional treatment trial for Partial Edentulism focused on measuring Dental implants, Trabecular Metal dental implants, TSV dental implants, Zimmer Dental, Implant stability, Implant stability quotient (ISQ), Resonance Frequency Analysis (RFA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Universitat Regensburg
Heinrich Heine Universitat Dusseldorf
Universitatsmedizin Mainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tapered Screw-vent implants (TSV)

Trabecular Metal dental implants (TM)

Arm Description

TSV implants to replace missing tooth/teeth

TM dental implants to replace missing tooth/teeth

Outcomes

Primary Outcome Measures

Implant Stability

Measure of Implant Stability Quotient immediately post implantation

Secondary Outcome Measures

Marginal bone level change

Measurement of bone level surrounding implant

Full Information

NCT ID

NCT02158377

First Posted

June 4, 2014

Last Updated

March 24, 2022

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT02158377

Brief Title

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

Acronym

TMEL

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 Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 2013 (Actual)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partial Edentulism, Tooth Disease

Keywords

Dental implants, Trabecular Metal dental implants, TSV dental implants, Zimmer Dental, Implant stability, Implant stability quotient (ISQ), Resonance Frequency Analysis (RFA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tapered Screw-vent implants (TSV)

Arm Type

Active Comparator

Arm Description

TSV implants to replace missing tooth/teeth

Arm Title

Trabecular Metal dental implants (TM)

Arm Type

Experimental

Arm Description

TM dental implants to replace missing tooth/teeth

Intervention Type

Device

Intervention Name(s)

Trabecular metal dental implants (TM)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Tapered screw-vent implants (TSV)

Intervention Description

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 Outcome Measure Information:

Title

Implant Stability

Description

Measure of Implant Stability Quotient immediately post implantation

Time Frame

3-18 weeks

Secondary Outcome Measure Information:

Title

Marginal bone level change

Description

Measurement of bone level surrounding implant

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilfried Wagner

Organizational Affiliation

Universitatsbedizin Mainz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitat Regensburg

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

Heinrich Heine Universitat Dusseldorf

City

Dusseldorf

State/Province

Nordhein-Westfalen

ZIP/Postal Code

40225

Country

Germany

Facility Name

Universitatsmedizin Mainz

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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

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