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Completed

NCT Number: NCT03554876

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Eduardo Anitua

Vitoria-Gasteiz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-Im Machined transepithelial component.

Device

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

Device

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

Device

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.

Primary outcomes

  1. Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants

    Time frame: 24 hours

  2. Total amount of the 25 most relevant bacterial species in peri-implantitis processes

    Time frame: 2 months

Secondary outcomes

  1. Total number of bacterial species.

    Time frame: 24 hours, 2 months

  2. Total amount of the 6 most abundant bacterial species.

    Time frame: 24 hours, 2 months

  3. Dental plaque index

    Time frame: Baseline, 24 hours, 2 months

  4. Gingival index of the natural teeth

    Time frame: Baseline, 24 hours, 2 months

  5. Probing depth of natural teeth

    Time frame: Baseline, 24 hours, 2 months

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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