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

Not Applicable

Completed

• Conditions: Biofilm Formation
• Interventions: Device: Multi-Im Machined transepithelial component.; Device: Multi-Im Ti-Golden transepithelial component; Device: Multi-Im Nanogolden transepithelial component

• Registration Number: NCT03554876
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Study Start: 2018-07-16
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Im Machined	Multi-Im Machined transepithelial component.	Multi-Im Machined
Multi-Im T-Golden	Multi-Im Ti-Golden transepithelial component	Multi-Im T-Golden
Multi-Im® nanogolden	Multi-Im Nanogolden transepithelial component	Multi-Im® nanogolden

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total amount of the 6 most abundant bacterial species.	24 hours, 2 months
Dental plaque index	Baseline, 24 hours, 2 months
Probing depth of natural teeth	Baseline, 24 hours, 2 months
Total number of bacterial species.	24 hours, 2 months
Gingival index of the natural teeth	Baseline, 24 hours, 2 months

Trial Locations

Locations (1)

Clínica Eduardo Anitua; 🇪🇸 Vitoria, Spain