Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Study Overview
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Brief Summary
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The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.

Official Title
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Evaluation of MT-12 Implant Survival and Marginal Bone Loss

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: MT-12 dental implant
* Device: CON.INT dental implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient >18 and ≤75 years old One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal) Exclusion Criteria: One-stage bone augmentation Uncontrolled type 1 or 2 diabetes (HgA1c>8) Known auto-immune or inflammatory disease Severe hematologic disorders, such as hemophilia or leukemia Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology) Liver or kidney dysfunction/failure Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy Long-term history of oral bisphosphonates use (i.e., 10 years or more) History of intravenous bisphosphonates Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion Severe osseous diseases (e.g., Paget disease of bone) Pregnant women or nursing mothers Not able or not willing to follow instructions related to the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-12 dental implant<br>MT-12 dental implant with Morse taper implant-abutment connection | Device: MT-12 dental implant<br>* Placement of the MT-12 dental implant with Morse taper implant-abutment connection<br>|
| Active Comparator: CON.INT dental implant<br>CON.INT dental implant with internal hexagon implant-abutment connection | Device: CON.INT dental implant<br>* Placement of the CON.INT dental implant with internal hexagon implant-abutment connection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone level |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant inflammation |  | 1 year | 
| Peri-implant microbial contamination |  | 1 year |