Denture StomatitisPhase 1NCT02950584
Surface Roughness of Heat Cured Acrylic Resin Versus Acrylic Resin With Titanium Dioxide
A Phase 1 study testing Titanium dioxide denture and Rapid heat denture in people with Denture Stomatitis, run by Cairo University.
Trial summary
Measurement of surface roughness of tow different material of denture base to find out which material is more hygienic by decreasing the amount of bacterial accumulation. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Titanium dioxide denture and Rapid heat denture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jun 2017
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relationship
- Healthy and co-operative patients
Who cannot join
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes/day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention
About this study
Official title: The Surface Roughness of Rapid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures: A Randomized Clinical Trials
Measurement of surface roughness of tow different material of denture base to find out which material is more hygienic by decreasing the amount of bacterial accumulation.
Read the detailed description
Using a denture base material as a standard value which is the rapid heat cured acrylic resin and compare it with a new material which is a conventional acrylic resin with addition of titanium dioxide nano particles in surface roughness and measuring it by a device called stylus profilometer this will be done on 20 patients this trial will take about 6 months.
- Conditions
- Denture Stomatitis
- Being tested
- Titanium dioxide denture, Rapid heat denture
- Medical subject headings
- Stomatitis, 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 design
Rapid heat dentureOther
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) according to the principle of crossover design
| Study group | Role | What they receive |
|---|---|---|
| Patients take titanium dioxide denture | Experimental | Participants 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; Other: Rapid heat 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; Other: Rapid heat denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Surface Roughness of the denture base will be measured and reported in micrometer unit
surface profilometry will be measured by stylus profilometer
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 posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture StomatitisStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, emad gamal ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950584
- Sponsor's protocol ID
- 89
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surface Roughness of Rapid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures: A Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT02950584
- Acronym / sponsor ID
- 89
- Conditions
- Denture Stomatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Measurement of surface roughness of tow different material of denture base to find out which material is more hygienic by decreasing the amount of bacterial accumulation.
Detailed description
Using a denture base material as a standard value which is the rapid heat cured acrylic resin and compare it with a new material which is a conventional acrylic resin with addition of titanium dioxide nano particles in surface roughness and measuring it by a device called stylus profilometer this will be done on 20 patients this trial will take about 6 months.
Study design
- 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 denture, Other: Rapid heat dentureParticipants 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 denture, Other: Rapid heat 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 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Completely edentulous maxillary arch and fully dentate mandibular arch with adequate interarch space.
- The edentulous ridges should be covered by firm healthy mucosa.
- Angle class I maxillomandibular relationship
- Healthy and co-operative patients
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/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 design | Other | Patients take rapid heat denture, Patients take titanium dioxide denture |
| Rapid heat 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) according to the principle of crossover design | Other | Patients take rapid heat denture, Patients take titanium dioxide denture |
Primary outcome
The Surface Roughness of the denture base will be measured and reported in micrometer unit
Time frame: 6 months
surface profilometry will be measured by stylus profilometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Denture Stomatitis
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Denture Stomatitis
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 Phase 1 study testing Titanium dioxide denture and Rapid heat denture in people with 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 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 1 Nov 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Surface Roughness of the denture base will be measured and reported in micrometer unit (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 1 Nov 2016.