Dental AnxietyNCT03006757
Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic
A study testing titanium dioxide denture base in people with Dental Anxiety, run by emad gamal ismail at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture . Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- titanium dioxide denture base
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space
- edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship
Who cannot join
- patients with bad habits
- previous history of radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud Adly
Giza, Giza Governorate, 002
mahmoudd 002 radwan, bachelor, 00201009714746 ext. 002, mahmoud_omega@yahoo.com
emad 002 gamal, bachelor, 01009714746 ext. 002, mahmoud_omega@yahoo.com
About this study
Official title: Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures
The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .
Read the detailed description
Bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .Determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. In addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system .
Twenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental Medicine, Cairo University.
The primary outcome is to measure the biting force of single maxillary complete denture by I Load star sensor .
- Conditions
- Dental Anxiety
- Being tested
- titanium dioxide denture base
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium dioxide denture baseOther
| Study group | Role | What they receive |
|---|---|---|
| Column titanium dioxide | Experimental | patient take titanium dioxide denture 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. Receives: Other: titanium dioxide denture base |
| column placebo | Experimental | patient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase Receives: Other: titanium dioxide denture base |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- emad gamal ismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, emad gamal ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006757
- Sponsor's protocol ID
- 900
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures
- ClinicalTrials.gov ID
- NCT03006757
- Acronym / sponsor ID
- 900
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- emad gamal ismailUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Dec 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.
The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .
Detailed description
Bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .Determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. In addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system .
Twenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental Medicine, Cairo University.
The primary outcome is to measure the biting force of single maxillary complete denture by I Load star sensor .
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Column titanium dioxide | Experimental | Other: titanium dioxide denture basepatient take titanium dioxide denture 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. |
| column placebo | Experimental | Other: titanium dioxide denture basepatient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space
- edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship
Key exclusion criteria (2 listed)
- patients with bad habits
- previous history of radiotherapy or chemotherapy
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 denture base | Other | Column titanium dioxide, column placebo |
Primary outcome
measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titanium dioxide denture base in people with Dental Anxiety, run by emad gamal ismail at 1 site in Egypt.
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 2 inclusion and 2 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact mahmoud adly radwan, master (00201009714746 ext. cairo, mahmoud_omega@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor (time frame: 3 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 30 Dec 2016.