Candida InfectionNCT03666195
The Anti-microbial Effect of Titanium Dioxide Nano Particles in Complete Dentures Made for Edentulous Patients
A study testing Titanium Dioxide Nanoparticles in people with Candida Infection and Denture Stomatitis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Candida Infection, Denture Stomatitis
- What is being tested?
- Titanium Dioxide Nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ranging from 40-70 years.
- Completely edentulous participants.
- Participants with well-developed ridges.
- Compliant participants
- Cooperative participants
- Male or female participants
Who cannot join
- 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
About this study
Official title: Anti-Microbial Effect of Titanium Dioxide Nano Particles Incorporated Acrylic Resin Denture Base Materials in Completely Edentulous Patients: A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Candida Infection, Denture Stomatitis
- Being tested
- Titanium Dioxide Nanoparticles
- Keywords
- Nanoparticles, Titanium dioxide, biofilm, self cleansing, denture plaque, anti microbial
- Medical subject headings
- Candidiasis, Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium Dioxide NanoparticlesCombination product
Also called Ultra fine titanium dioxide, TiO2
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | complete dentures will be fabricated using poly methyl methacrylate resin denture base material modified with 5%wt titanium dioxide nanoparticles. Receives: Combination Product: Titanium Dioxide Nanoparticles |
| Group B | No intervention | complete dentures will be fabricated with poly methyl methacrylate resin denture base material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Growth
Bacterial colony forming units
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start15 Oct 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Ibrahim Badran, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666195
- Sponsor's protocol ID
- Mona's Protocol
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Microbial Effect of Titanium Dioxide Nano Particles Incorporated Acrylic Resin Denture Base Materials in Completely Edentulous Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03666195
- Acronym / sponsor ID
- Mona's Protocol
- Conditions
- Candida Infection, Denture Stomatitis
- Keywords
- Nanoparticles, Titanium dioxide, biofilm, self cleansing, denture plaque, anti microbial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Jan 2019 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Combination Product: Titanium Dioxide Nanoparticlescomplete dentures will be fabricated using poly methyl methacrylate resin denture base material modified with 5%wt titanium dioxide nanoparticles. |
| Group B | No intervention | –complete dentures will be fabricated with poly methyl methacrylate resin denture base material. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ranging from 40-70 years.
- Completely edentulous participants.
- Participants with well-developed ridges.
- Compliant participants
- Cooperative participants
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titanium Dioxide NanoparticlesAlso: Ultra fine titanium dioxide, TiO2incorporating 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 | Combination product | Group A |
Primary outcome
Bacterial Growth
Time frame: 1 month
Bacterial colony forming units
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium Dioxide Nanoparticles in people with Candida Infection and Denture Stomatitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Growth (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.