Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection

Study Overview
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Brief Summary
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Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.

Official Title
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Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Ziacom Galaxy dental implant with internal connical prosthetic connection
* Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ziacom Galaxy dental implant with internal connical prosthetic connection<br>Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection | Device: Ziacom Galaxy dental implant with internal connical prosthetic connection<br>* Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection<br>|
| Active Comparator: Ziacom Zinic dental implant with internal hexagonal prosthetic connection<br>Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection | Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connection<br>* Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic 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 microbiome | Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods | 1 year | 
| Peri-implant inflammation | Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods | 1 year |