Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components

Study Overview
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Brief Summary
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This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion. The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.

Official Title
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Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components Placed on Implants

Conditions
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Biofilm Formation

Intervention / Treatment
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* Device: Multi-Im Machined transepithelial component.
* Device: Multi-Im Nanogolden transepithelial component
* Device: Multi-Im Ti-Golden transepithelial component


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication of having to place at least three dental implants. Plate index ≤ 20% and absence of evidence of active periodontal disease. Bleeding index of adjacent teeth ≤ 30%. Probing depth in adjacent teeth <4 mm. Not having used systemic antibiotics during the last 6 months. Non smoker. Possibility for observation during the treatment period. Having signed the informed consent. Exclusion Criteria: Suffering any alteration or serious hematologic disease. Being undergoing or having received in the 30 days prior to inclusion: radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants. Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement. Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously. Metabolic bone disease. Diseases that affect the oral mucosa. Diabetic patients. Severe parafunctional habits and/or temporomandibular joint disorders. Pregnant or lactating women. Physical or mental inability to maintain a good oral hygiene. Being participating in another study. In general, any inability to participate in the study.

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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No

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 |
| --- | --- |
| Active Comparator: Multi-Im Machined<br>Multi-Im Machined | Device: Multi-Im Machined transepithelial component.<br>* Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM machined transepithelial component is connected to the implant.<br>|
| Experimental: Multi-Im® nanogolden<br>Multi-Im® nanogolden | Device: Multi-Im Nanogolden transepithelial component<br>* Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Nanogolden transepithelial component is connected to the implant.<br>|
| Experimental: Multi-Im T-Golden<br>Multi-Im T-Golden | Device: Multi-Im Ti-Golden transepithelial component<br>* Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Ti-Golden transepithelial component is connected to the implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants |  | 24 hours | 
| Total amount of the 25 most relevant bacterial species in peri-implantitis processes |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of bacterial species. |  | 24 hours, 2 months | 
| Total amount of the 6 most abundant bacterial species. |  | 24 hours, 2 months | 
| Dental plaque index |  | Baseline, 24 hours, 2 months | 
| Gingival index of the natural teeth |  | Baseline, 24 hours, 2 months | 
| Probing depth of natural teeth |  | Baseline, 24 hours, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofilm, peri-implantitis, metagenomic analysis, abutment