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
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
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
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
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
Learn more about this trial
The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients
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