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

Primary Purpose

Biofilm Formation

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multi-Im Machined transepithelial component.
Multi-Im Nanogolden transepithelial component
Multi-Im Ti-Golden transepithelial component
Sponsored by
Fundación Eduardo Anitua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biofilm Formation focused on measuring Biofilm, peri-implantitis, metagenomic analysis, abutment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Eduardo AnituaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Multi-Im Machined

Multi-Im® nanogolden

Multi-Im T-Golden

Arm Description

Multi-Im Machined

Multi-Im® nanogolden

Multi-Im T-Golden

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total number of bacterial species.
Total amount of the 6 most abundant bacterial species.
Dental plaque index
Gingival index of the natural teeth
Probing depth of natural teeth

Full Information

First Posted
May 30, 2018
Last Updated
September 14, 2021
Sponsor
Fundación Eduardo Anitua
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1. Study Identification

Unique Protocol Identification Number
NCT03554876
Brief Title
Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components
Official Title
Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components Placed on Implants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Eduardo Anitua

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biofilm Formation
Keywords
Biofilm, peri-implantitis, metagenomic analysis, abutment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Im Machined
Arm Type
Active Comparator
Arm Description
Multi-Im Machined
Arm Title
Multi-Im® nanogolden
Arm Type
Experimental
Arm Description
Multi-Im® nanogolden
Arm Title
Multi-Im T-Golden
Arm Type
Experimental
Arm Description
Multi-Im T-Golden
Intervention Type
Device
Intervention Name(s)
Multi-Im Machined transepithelial component.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-Im Nanogolden transepithelial component
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-Im Ti-Golden transepithelial component
Intervention Description
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 Outcome Measure Information:
Title
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
Time Frame
24 hours
Title
Total amount of the 25 most relevant bacterial species in peri-implantitis processes
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Total number of bacterial species.
Time Frame
24 hours, 2 months
Title
Total amount of the 6 most abundant bacterial species.
Time Frame
24 hours, 2 months
Title
Dental plaque index
Time Frame
Baseline, 24 hours, 2 months
Title
Gingival index of the natural teeth
Time Frame
Baseline, 24 hours, 2 months
Title
Probing depth of natural teeth
Time Frame
Baseline, 24 hours, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Hamdan, PhD
Phone
0034945160653
Email
mohammad.hamdan@bti-implant.es
Facility Information:
Facility Name
Clínica Eduardo Anitua
City
Vitoria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Anitua

12. IPD Sharing Statement

Learn more about this trial

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

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