Effect of Tio2 Nanoparticles on Candida AggregationNCT03700489
Mycological Comparative Study on Maxillary Dentures of Two Different Materials
A study testing titanium dioxide denture in people with Effect of Tio2 Nanoparticles on Candida Aggregation, run by Ali ibrahim mahmoud shamardal.
Trial summary
Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Tio2 Nanoparticles on Candida Aggregation
- What is being tested?
- titanium dioxide denture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 1 Jun 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relation.
- Healthy and cooperative patient
Who cannot join
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention
About this study
Official title: Mycological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cure Acrylic Resin Material and Conventional Acrylic Resin Material Modified by Titanium Dioxide Nanoparticles
Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the candida species
- Being tested
- titanium dioxide denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium dioxide dentureOther
patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover des
| Study group | Role | What they receive |
|---|---|---|
| patients take titanium dioxide denture | Experimental | patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial then in the later phase after one month they will receive( rapid heat cured acrylic resin)denture Receives: Other: titanium dioxide denture |
| patients take rapid heat denture | Placebo comparator | patients will receive rapid heat denture for 1 month in the initial phase of the trial then in the later phase patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) Receives: Other: titanium dioxide denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological investigation
Count of candida on the fitting surface of denture by (CFU) unit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Tio2 Nanoparticles on Candida AggregationStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali ibrahim mahmoud shamardal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali ibrahim mahmoud shamardal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700489
- Sponsor's protocol ID
- Acrylic vs Tio2 reinforced
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cure Acrylic Resin Material and Conventional Acrylic Resin Material Modified by Titanium Dioxide Nanoparticles
- ClinicalTrials.gov ID
- NCT03700489
- Acronym / sponsor ID
- Acrylic vs Tio2 reinforced
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ali ibrahim mahmoud shamardalUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 9 Oct 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.
Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the candida species
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients take titanium dioxide denture | Experimental | Other: titanium dioxide denturepatients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial then in the later phase after one month they will receive( rapid heat cured acrylic resin)denture |
| patients take rapid heat denture | Placebo comparator | Other: titanium dioxide denturepatients will receive rapid heat denture for 1 month in the initial phase of the trial then in the later phase patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relation.
- Healthy and cooperative patient
Key exclusion criteria (3 listed)
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention
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 denturepatients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover des | Other | patients take rapid heat denture, patients take titanium dioxide denture |
Primary outcome
Mycological investigation
Time frame: 6 months
Count of candida on the fitting surface of denture by (CFU) unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: Undecided
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 denture in people with Effect of Tio2 Nanoparticles on Candida Aggregation, run by Ali ibrahim mahmoud shamardal.
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 4 inclusion and 3 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 9 Oct 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. Some participants in this study may receive a placebo. 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?
Mycological investigation (time frame: 6 months). 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 9 Oct 2018; AzTrials last refreshed its copy on 4 Nov 2026.