Dental MalocclusionNCT03714932
Accuracy of Arch Analysis in Mixed Dentition Using Digital Models Versus Plaster Ones.
An observational study of Dental Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation: Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- 3shape ortho analyzer software
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 20 Sep 2020
- 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 6 to 10 years
- All sexes
- Child
Study population: Children aged six to Ten years.
Who may be able to join
- Aged range from 6-10.
- patients medically free from any syndromes that could affect the normal eruption.
- Normal radiographical findings in teeth eruption.
- Erupted lower incisors.
Who cannot join
- Extracted lower 1st permanent molar.
- congenital missing of incisors.
- Badly decayed permanent incisors or 1st molar that could compromise the measurements.
- Any sensitivity to any of the impression materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Arch Analysis in Mixed Dentition Using Digital Study Models Versus the Plaster Models Using Tanaka and Johnston Prediction Equation:
Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation:
Read the detailed description
Space analysis is traditionally performed by diagnostic measurements that have been obtained from plaster dental casts through measurements which might be influenced by subjective interpretation and bias when constructed.
*So another method of diagnostically measuring study models was introduced (Digital software). This system creates digital images of dental casts with software. From the digitized models, various analyses and routine measurements could be done that might accelerate and solve many problems and difficulties associated with storage, retrieval, reproduction, communication, and breakage of conventional plaster casts.
- Taking an impressions for a mixed dentition aged children.
- Perform a measurements using Tanaka and Johnston equation for an arch analysis using a caliper and 3Shape ortho-analyzer software.
- Casts will be scanned using the 3D scanner then by using the 3shape software measurements will be held according to Tanaka and Johnstopn prediction equation.
- Conditions
- Dental Malocclusion
- Being tested
- 3shape ortho analyzer software
- Keywords
- Arch analysis, Mixed dentition,Tanaka & Johnston
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3shape ortho analyzer softwareDiagnostic test
Arch analysis , manual analysis , digital analysis , Mixed dentition , Tanaka and Johnston
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of digital models in arch analysis.
using digital models through software(3shape ortho analyzer) to evaluate it's accuracy in arch analysis through prediction equation(Tanaka and Johnston equations)versus plaster models by using manual caliper.
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 posted22 Oct 2018
- Study start1 Oct 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion20 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies 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, Sara Mohamed Tag El Deen, Cairo University
- Investigators
- sara Mohamed Tag El Deen, Master, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714932
- Sponsor's protocol ID
- CEBD-CU-2018-09-36
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2018
- Last updated
- 3 Sep 2020
- 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 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Arch Analysis in Mixed Dentition Using Digital Study Models Versus the Plaster Models Using Tanaka and Johnston Prediction Equation:
- ClinicalTrials.gov ID
- NCT03714932
- Acronym / sponsor ID
- CEBD-CU-2018-09-36
- Conditions
- Dental Malocclusion
- Keywords
- Arch analysis, Mixed dentition,Tanaka & Johnston
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 22 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.
Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation:
Detailed description
Space analysis is traditionally performed by diagnostic measurements that have been obtained from plaster dental casts through measurements which might be influenced by subjective interpretation and bias when constructed.
*So another method of diagnostically measuring study models was introduced (Digital software). This system creates digital images of dental casts with software. From the digitized models, various analyses and routine measurements could be done that might accelerate and solve many problems and difficulties associated with storage, retrieval, reproduction, communication, and breakage of conventional plaster casts.
- Taking an impressions for a mixed dentition aged children.
- Perform a measurements using Tanaka and Johnston equation for an arch analysis using a caliper and 3Shape ortho-analyzer software.
- Casts will be scanned using the 3D scanner then by using the 3shape software measurements will be held according to Tanaka and Johnstopn prediction equation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged six to Ten years.
Key inclusion criteria (4 listed)
- Aged range from 6-10.
- patients medically free from any syndromes that could affect the normal eruption.
- Normal radiographical findings in teeth eruption.
- Erupted lower incisors.
Key exclusion criteria (4 listed)
- Extracted lower 1st permanent molar.
- congenital missing of incisors.
- Badly decayed permanent incisors or 1st molar that could compromise the measurements.
- Any sensitivity to any of the impression materials.
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 |
|---|---|---|
| 3shape ortho analyzer softwareArch analysis , manual analysis , digital analysis , Mixed dentition , Tanaka and Johnston | Diagnostic test | – |
Primary outcome
accuracy of digital models in arch analysis.
Time frame: 6 months
using digital models through software(3shape ortho analyzer) to evaluate it's accuracy in arch analysis through prediction equation(Tanaka and Johnston equations)versus plaster models by using manual caliper.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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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.
sara Mohamed Tag El Deen, Master study director
Cairo University
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 Dental Malocclusion, 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 4 inclusion and 4 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 3 Sep 2020. 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 sara Mohamed Tag El Deen, master (01066960533, sara-mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of digital models in arch analysis. (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 3 Sep 2020.