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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-12-22

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.

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Detailed Description

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Conditions

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Biofilm Formation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multi-Im Machined

Group Type ACTIVE_COMPARATOR

Multi-Im Machined transepithelial component.

Intervention Type DEVICE

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.

Multi-Im® nanogolden

Group Type EXPERIMENTAL

Multi-Im Nanogolden transepithelial component

Intervention Type DEVICE

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.

Multi-Im T-Golden

Group Type EXPERIMENTAL

Multi-Im Ti-Golden transepithelial component

Intervention Type DEVICE

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.

Interventions

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Multi-Im Machined transepithelial component.

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.

Intervention Type DEVICE

Multi-Im Nanogolden transepithelial component

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.

Intervention Type DEVICE

Multi-Im Ti-Golden transepithelial component

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No