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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: Trabecular metal dental implants (TM)
* Device: Tapered screw-vent implants (TSV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Trabecular Metal dental implants, TSV dental implants, Zimmer Dental, Implant stability, Implant stability quotient (ISQ), Resonance Frequency Analysis (RFA)