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

Biofilm Formation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03554876
• Other study ID #: FIBEA-06-EC/17/Multi-Im
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Fundación Eduardo Anitua
• Contact: Mohammad Hamdan, PhD
• Phone: 0034945160653
• Email: mohammad.hamdan[@]bti-implant.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biofilm Formation
• Tissue Adhesions

Intervention

Device:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Clínica Eduardo Anitua	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants		24 hours
Primary	Total amount of the 25 most relevant bacterial species in peri-implantitis processes		2 months
Secondary	Total number of bacterial species.		24 hours, 2 months
Secondary	Total amount of the 6 most abundant bacterial species.		24 hours, 2 months
Secondary	Dental plaque index		Baseline, 24 hours, 2 months
Secondary	Gingival index of the natural teeth		Baseline, 24 hours, 2 months
Secondary	Probing depth of natural teeth		Baseline, 24 hours, 2 months