Clinical trial NCT03554876: Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components
Official title: Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components Placed on Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biofilm Formation
Keywords: Biofilm
peri-implantitis
metagenomic analysis
abutment
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
timeFrame: 24 hours
measure: Total amount of the 25 most relevant bacterial species in peri-implantitis processes
timeFrame: 2 months
Secondary outcomes:
measure: Total number of bacterial species.
timeFrame: 24 hours, 2 months
measure: Total amount of the 6 most abundant bacterial species.
timeFrame: 24 hours, 2 months
measure: Dental plaque index
timeFrame: Baseline, 24 hours, 2 months
measure: Gingival index of the natural teeth
timeFrame: Baseline, 24 hours, 2 months
measure: Probing depth of natural teeth
timeFrame: Baseline, 24 hours, 2 months
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clínica Eduardo Anitua
Study officials:
References: