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

Fundación Eduardo Anitua

Status: Completed

Conditions: Biofilm Formation

Treatments: Device: Multi-Im Ti-Golden transepithelial component; Device: Multi-Im Nanogolden transepithelial component; Device: Multi-Im Machined transepithelial component.

Study type: Interventional

Funder types: Other

Identifiers

NCT03554876

FIBEA-06-EC/17/Multi-Im

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 3 patient groups

Multi-Im Machined

Active Comparator group

Description:

Multi-Im Machined

Treatment:

Device: Multi-Im Machined transepithelial component.

Multi-Im® nanogolden

Experimental group

Description:

Multi-Im® nanogolden

Treatment:

Device: Multi-Im Nanogolden transepithelial component

Multi-Im T-Golden

Experimental group

Description:

Multi-Im T-Golden

Treatment:

Device: Multi-Im Ti-Golden transepithelial component