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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Biofilm Formation
• Intervention / Treatment: Device: Multi-Im Machined transepithelial component.; Device: Multi-Im Nanogolden transepithelial component; Device: Multi-Im Ti-Golden transepithelial component

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Hamdan, PhD; Phone Number: 0034945160653; Email: mohammad.hamdan@bti-implant.es

Study Locations

• Spain
  • Vitoria, Spain
    • Recruiting
    • Clinica Eduardo Anitua
    • Contact: Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Multi-Im Machined	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.
EXPERIMENTAL: Multi-Im® nanogolden	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.
EXPERIMENTAL: Multi-Im T-Golden	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2018
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (ACTUAL): June 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Biofilm; peri-implantitis; metagenomic analysis; abutment
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: FIBEA-06-EC/17/Multi-Im

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No