Biofilm Formation
Conditions
Keywords
Biofilm, peri-implantitis, metagenomic analysis, abutment
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.
Interventions
DEVICEMulti-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.
DEVICEMulti-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.
DEVICEMulti-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.
Sponsors
Fundación Eduardo Anitua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Dental plaque index | Baseline, 24 hours, 2 months |
| Total number of bacterial species. | 24 hours, 2 months |
| Probing depth of natural teeth | Baseline, 24 hours, 2 months |
| Gingival index of the natural teeth | Baseline, 24 hours, 2 months |
| Total amount of the 6 most abundant bacterial species. | 24 hours, 2 months |
Countries
Spain
Outcome results
None listed