Partial EdentulismTMELNCT02158377
TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas
A study testing Trabecular metal dental implants (TM) and Tapered screw-vent implants (TSV) in people with Partial Edentulism and Tooth Disease, run by ZimVie at 3 sites in Germany.
Trial summary
Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism, Tooth Disease
- What is being tested?
- Trabecular metal dental implants (TM) and Tapered screw-vent implants (TSV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Heinrich Heine Universitat Dusseldorf
Düsseldorf, Nordhein-Westfalen, 40225
Universitatsmedizin Mainz
Mainz, Rhineland-Palatinate, 55131
Universitat Regensburg
Regensburg, Bavaria, 93053
About this study
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.
Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.
Read the 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.
- Conditions
- Partial Edentulism, Tooth Disease
- Being tested
- Trabecular metal dental implants (TM), Tapered screw-vent implants (TSV)
- Keywords
- Dental implants, Trabecular Metal dental implants, TSV dental implants, Zimmer Dental, Implant stability, Implant stability quotient (ISQ), Resonance Frequency Analysis (RFA)
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Tapered Screw-vent implants (TSV) | Active comparator | TSV implants to replace missing tooth/teeth Receives: Device: Tapered screw-vent implants (TSV) |
| Trabecular Metal dental implants (TM) | Experimental | TM dental implants to replace missing tooth/teeth Receives: Device: Trabecular metal dental implants (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability
Measure of Implant Stability Quotient immediately post implantation
Measured: 3-18 weeks
Secondary outcomes (1)
Marginal bone level change
Measurement of bone level surrounding implant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried Wagner, Principal investigator, Universitatsbedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158377
- Sponsor's protocol ID
- CSU2011-08D
- Acronym
- TMEL
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2014
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02158377
- Acronym / sponsor ID
- TMEL / CSU2011-08D
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapered Screw-vent implants (TSV) | Active comparator | Device: Tapered screw-vent implants (TSV)TSV implants to replace missing tooth/teeth |
| Trabecular Metal dental implants (TM) | Experimental | Device: Trabecular metal dental implants (TM)TM dental implants to replace missing tooth/teeth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Trabecular Metal dental implants (TM) |
| 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. | Device | Tapered Screw-vent implants (TSV) |
Primary outcome
Implant Stability
Time frame: 3-18 weeks
Measure of Implant Stability Quotient immediately post implantation
1 secondary outcome
Marginal bone level change
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Partial Edentulism
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
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Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried Wagner principal investigator
Universitatsbedizin Mainz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabecular metal dental implants (TM) and Tapered screw-vent implants (TSV) in people with Partial Edentulism and Tooth Disease, run by ZimVie at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (time frame: 3-18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.