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The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients

Primary Purpose

Candida Infection, Denture Stomatitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Titanium Dioxide Nanoparticles
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Candida Infection focused on measuring Nanoparticles, Titanium dioxide, biofilm, self cleansing, denture plaque, anti microbial

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ranging from 40-70 years.
  2. Completely edentulous participants.
  3. Participants with well-developed ridges.
  4. Compliant participants
  5. Cooperative participants
  6. Male or female participants

Exclusion Criteria:

  1. Pathological changes of residual ridges.
  2. Participants with any debilitating disease.
  3. Participants with uncontrolled diabetes.
  4. Participants with allergy to resins.
  5. Participants with allergy to titanium dioxide nanoparticles.
  6. Participants with severe undercuts, or irregular bony exostosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Group A

    Group B

    Arm Description

    complete dentures will be fabricated using poly methyl methacrylate resin denture base material modified with 5%wt titanium dioxide nanoparticles.

    complete dentures will be fabricated with poly methyl methacrylate resin denture base material.

    Outcomes

    Primary Outcome Measures

    Bacterial Growth
    Bacterial colony forming units

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2018
    Last Updated
    September 10, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03666195
    Brief Title
    The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients
    Official Title
    Anti-Microbial Effect of Titanium Dioxide Nano Particles Incorporated Acrylic Resin Denture Base Materials in Completely Edentulous Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2018 (Anticipated)
    Primary Completion Date
    December 15, 2018 (Anticipated)
    Study Completion Date
    January 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Although cleaning dentures by immersion in chemical denture cleaning solutions is effective in reducing the number of bacteria, a large number remains adhering to the denture surface. Thus, the mechanical cleansing of dentures is imperative to remove adherent microbes, and prevent diseases. This is not always easy to achieve, due to un-compliant patients, or patients with diminished manual dexterity (e.g. Mani phalanx dysfunction or Rheumatoid Arthritis) that often require assistance in cleaning their dentures, which may not always be available. Therefore, the modification of denture base materials to provide them with antibacterial properties to control oral biofilm formation, and producing dentures that can be cleaned by simply rinsing in water would prove to be valuable in oral hygienic management in complete denture-wearing patients.
    Detailed Description
    Nanoparticulate Metals as Antimicrobial Agents Many of the major medical breakthroughs in history, have been largely dependent on the antimicrobial effects of different metals. Mercury has been used medicinally in the treatment of syphilis, and skin diseases as far back as the 10th century in Europe, and 2nd Century BC in China. And till this day organomercurial compounds remain in use for their antiseptic, and disinfectant properties. Metals such as copper and zinc are now incorporated in micron size, in products such as toothpastes, to control dental plaque formation. More recently, the addition of nanoparticulate metals such as TiO2, SiO2, ZnO, Ag, CuO to dental materials to impart an antimicrobial effect, has been investigated in many studies. Among these metals, titanium dioxide nanoparticles have received the most attention due to its white color, low toxicity at concentrations usually used, high stability, availability, and its high photocatalytic activity. Many studies suggested that incorporating titanium dioxide nanoparticles to PMMA, significantly decreases porosities in the denture resin, rendering titanium dioxide nanoparticles a suitable additive to denture base materials. Titanium Dioxide as a Photocatalyst In 1977 Frank and Bard were the first to study the possibilities of using TiO2 to degrade cyanide in water, since then, there has been growing interest in its various applications. Titanium dioxide is a light-sensitive semiconductor, that absorbs electromagnetic radiation in the near UV region. Absorbing light energy causes an electron to be promoted from the valence band to the conduction band. Water molecules which are commonly adsorbed onto the titanium dioxide surface, are oxidized in the process, generating OH• radicals. These free radicals are characterized by a high level of energy enabling them to react with different organic compounds such as the polyunsaturated phospholipid component of the microbial lipid membrane that eventually leads to their complete oxidation to carbon dioxide and water, inhibiting the microorganisms' respiratory activity, and eliciting cell death. Recent studies have proved the antimicrobial effects of titanium dioxide against Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Lactobacillus acidophilus, and MRSA. However, there are recent concerns titanium dioxide could be cited as a health hazard, as it could produce tissue inflammation as generated by cytokine release. Moreover, adding TiO2 nanoparticles can alter the physical properties of the substrate. It has been found that adding as much as 5%wt of TiO2 nanoparticles to PMMA does not produce deleterious effects on the mechanical properties of the material, while concentrations required to produce an inhibitory or a killing effect on microorganisms has been found to be 0.25-2.5 mg/mL

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Candida Infection, Denture Stomatitis
    Keywords
    Nanoparticles, Titanium dioxide, biofilm, self cleansing, denture plaque, anti microbial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The outcome assessor will be blinded as well as the statistician and the participant. The outcome assessor will count the bacterial colony forming units without knowing the type of the denture material used (Conventional acrylic resin or acrylic resin modified by titanium dioxide nanoparticles)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    complete dentures will be fabricated using poly methyl methacrylate resin denture base material modified with 5%wt titanium dioxide nanoparticles.
    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    complete dentures will be fabricated with poly methyl methacrylate resin denture base material.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Titanium Dioxide Nanoparticles
    Other Intervention Name(s)
    Ultra fine titanium dioxide, TiO2
    Intervention Description
    incorporating titanium dioxide nanoparticles to PMMA, significantly decreases porosities in the denture resin, rendering titanium dioxide nanoparticles a suitable additive to denture base materials, as it also exhibits anti-microbial effects
    Primary Outcome Measure Information:
    Title
    Bacterial Growth
    Description
    Bacterial colony forming units
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ranging from 40-70 years. Completely edentulous participants. Participants with well-developed ridges. Compliant participants Cooperative participants Male or female participants Exclusion Criteria: Pathological changes of residual ridges. Participants with any debilitating disease. Participants with uncontrolled diabetes. Participants with allergy to resins. Participants with allergy to titanium dioxide nanoparticles. Participants with severe undercuts, or irregular bony exostosis

    12. IPD Sharing Statement

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    The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients

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