Orthodontic Appliance ComplicationNCT03552640
Accuracy of Digital Three-Dimensional Root Position Prediction Via Digitized Models
An observational study of Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Measuring the accuracy of a new technique by which root positions can be predicted at the pre-finishing stage of the comprehensive orthoodntic treatment Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Orthodontic Appliance Complication
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2018to Sep 2019
- Phase
- Observational
- 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 12 to 30 years
- All sexes
- Child, Adult
Study population: Patients having only permenant teeth and no decidous ones, requiring orthodontic treatment not involving extraction of teeth in their treatment plan
Who may be able to join
- Patients requiring orthodontic treatment
- Adult set of permanent dentition
- Non-extraction cases
Who cannot join
- Syndromic patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Orthodontic Department
Cairo, 11553
Mai Hamdy Aboul Fotouh, PhD, +201001884499, maihamdi@gmail.com
Amr Ragab El Bialy, PhD, +20 100 660 7277, amrelbeialy@gmail.com
About this study
Measuring the accuracy of a new technique by which root positions can be predicted at the pre-finishing stage of the comprehensive orthoodntic treatment
Read the detailed description
A CBCT is taken Pre-Treatment
Segmentation of teeth is done from the CBCT exported as STL files and kept aside.
Routine comprehensive orthodontic treatment is done till pre-finishing stage.
Impression for teeth is taken at this timepoint.
A cast is poured and laser scanned.
Now the investigators have segmented teeth and a cast with new crown positions
The investigators will superimpose the teeth on the crowns of the digital cast to obtain the " Predicted Root Position" (PRP)
To check accuracy of this Prediction a CBCT is taken and compared to the prediction to check its accuracy.
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontics, Digitized Models, Root Position
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Root Position Prediction as assessed by Color Map Heat Analysis
Using Color Map Heat Analysis in millimetres
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startAug 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdullah El-Gendi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552640
- Sponsor's protocol ID
- CEBD-CU-2018-04-19
- Status last verified
- Aug 2018
- First submitted
- 25 Apr 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Digital Three-Dimensional Root Position Prediction Via Digitized Models
- ClinicalTrials.gov ID
- NCT03552640
- Acronym / sponsor ID
- CEBD-CU-2018-04-19
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontics, Digitized Models, Root Position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Jun 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.
Measuring the accuracy of a new technique by which root positions can be predicted at the pre-finishing stage of the comprehensive orthoodntic treatment
Detailed description
A CBCT is taken Pre-Treatment
Segmentation of teeth is done from the CBCT exported as STL files and kept aside.
Routine comprehensive orthodontic treatment is done till pre-finishing stage.
Impression for teeth is taken at this timepoint.
A cast is poured and laser scanned.
Now the investigators have segmented teeth and a cast with new crown positions
The investigators will superimpose the teeth on the crowns of the digital cast to obtain the " Predicted Root Position" (PRP)
To check accuracy of this Prediction a CBCT is taken and compared to the prediction to check its accuracy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients having only permenant teeth and no decidous ones, requiring orthodontic treatment not involving extraction of teeth in their treatment plan
Key inclusion criteria (3 listed)
- Patients requiring orthodontic treatment
- Adult set of permanent dentition
- Non-extraction cases
Key exclusion criteria (1 listed)
- Syndromic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of Root Position Prediction as assessed by Color Map Heat Analysis
Time frame: 9 months
Using Color Map Heat Analysis in millimetres
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Appliance Complication, 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 3 inclusion and 1 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 21 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Root Position Prediction as assessed by Color Map Heat Analysis (time frame: 9 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 21 Aug 2018.