Bites, HumanNCT02996123
Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases
A study testing cad/cam maxillary dentures in people with Bites, Human, run by Cairo University at 1 site in Egypt.
Trial summary
measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bites, Human
- What is being tested?
- cad/cam maxillary dentures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.
- Mean age of 50-75 years of age.
- The edentulous ridges should be covered by firm healthy mucosa.
- Systemically free; no history of diabetes, chemotherapy, and radiotherapy.
- Co-operative patients.
Who cannot join
- Patients with severely resorbed maxillary ridge
- Previous history of radiotherapy or chemotherapy.
- Patients with xerostomia
- Patients with neuromuscular and hormonal disorders
- Patients with severe bony or soft tissue undercuts
- Patients with large tongue
- Patients with limited mouth opening
- Patients with known history of allergy, especially to acrylic resin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled Trial .
measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.
Read the detailed description
measuring difference in biting force using i-load device with followup period of 6 months
- Conditions
- Bites, Human
- Being tested
- cad/cam maxillary dentures
- Medical subject headings
- Bites, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cad/cam maxillary denturesOther
patients wearing cad/cam designed and milled dentures
| Study group | Role | What they receive |
|---|---|---|
| cad/cam maxillary dentures | Experimental | single maxillary dentures fabricated by cad/cam method Receives: Other: cad/cam maxillary dentures |
| conventional dentures | Active comparator | heat cured single maxillary dentures Receives: Other: cad/cam maxillary dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- 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 Bites, HumanStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Erfan Gamal El Dein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996123
- Sponsor's protocol ID
- EKF 54324
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: charts with measurements and readings collected will be recorded and available
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biting Force in Heat Cured Acrylic Resin Versus CAD/CAM Maxillary Single Denture Bases: A Randomized Controlled Trial .
- ClinicalTrials.gov ID
- NCT02996123
- Acronym / sponsor ID
- EKF 54324
- Conditions
- Bites, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 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.
measuring difference in biting force between (computer aided design/computer aided manufacturing) maxillary dentures and conventional ones.
Detailed description
measuring difference in biting force using i-load device with followup period of 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cad/cam maxillary dentures | Experimental | Other: cad/cam maxillary denturessingle maxillary dentures fabricated by cad/cam method |
| conventional dentures | Active comparator | Other: cad/cam maxillary denturesheat cured single maxillary dentures |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with completely edentulous maxillary ridge with minimum undercuts, opposing a partially edentulous ridge.
- Mean age of 50-75 years of age.
- The edentulous ridges should be covered by firm healthy mucosa.
- Systemically free; no history of diabetes, chemotherapy, and radiotherapy.
- Co-operative patients.
Key exclusion criteria (8 listed)
- Patients with severely resorbed maxillary ridge
- Previous history of radiotherapy or chemotherapy.
- Patients with xerostomia
- Patients with neuromuscular and hormonal disorders
- Patients with severe bony or soft tissue undercuts
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 |
|---|---|---|
| cad/cam maxillary denturespatients wearing cad/cam designed and milled dentures | Other | cad/cam maxillary dentures, conventional dentures |
Primary outcome
Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: Yes. charts with measurements and readings collected will be recorded and available
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cad/cam maxillary dentures in people with Bites, Human, run by Cairo University 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 5 inclusion and 8 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 19 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?
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?
Biting Force in Heat Cured acrylic resin versus CAD/CAM Maxillary Single Denture Bases (time frame: 6 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 19 Dec 2016.