Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - AssessmentNCT06019351
Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.
An observational study of Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - Assessment, run by Cairo University at 1 site in Egypt.
Trial summary
Digital transformation in the orthodontic field profoundly alters the way in which orthodontic treatment is perceived and delivered, moreover it aids in creating individualized orthodontic appliances.A crucial step in digital orthodontic planning in either indirect bonding or aligner treatment is localization of… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - Assessment
- What is being tested?
- OrthoAnalyzer™ software
- Type of treatment
- Medical device
- How many people
- 141 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2022to 21 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.
Who may be able to join
- Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.
- Justified CBCT record taken for impacted and ectopic teeth, planning for MARPE (mini-screw assisted rapid palatal expansion)/MSE (maxillary skeletal expansion), critical tooth movements in periodontally compromised patients, surgery first cases, taken for previous studies and other reasons.
Who cannot join
- Severe crowding.
- Teeth with bizarre anatomy or severely decayed.
- Patients in mixed dentition stage.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, El Manial, 35855
kholoud khaled, 01001128434
dentmail@dentistry.cu.edu.eg
About this study
Digital transformation in the orthodontic field profoundly alters the way in which orthodontic treatment is perceived and delivered, moreover it aids in creating individualized orthodontic appliances.A crucial step in digital orthodontic planning in either indirect bonding or aligner treatment is localization of mesiodistal tip. Earlier, Panoramic radiographs were formerly recommended to assist clinicians in properly identifying mesiodistal root angulation. recommended to help clinician to identify mesiodistal root angulation accurately. Owens et al. recorded clinically significant variation between the radiographic and the true root angulation. Alternatively CBCT (Cone Beam Computed Tomography) guided mesiodistal root angulation assessment has superior clinical significance compared to the routinely taken panoramic radiograph . despite its accuracy ,CBCT is not justified as a part of diagnostic records for orthodontic treatment planning following the ALARA rule . To eliminate additional x ray dose Computer aided mesiodistal root angulation identification is provided by several softwares such as OrthoAnalyzer™ ,OrthoCAD® ,and SureSmile® , however, the accuracy remains questionable. These finding may point out the importance of studying the accuracy mesiodistal identification to carry on digital workflow without the radiographic guidance.
- Being tested
- OrthoAnalyzer™ software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoAnalyzer™ softwareDevice
OrthoAnalyzer™ software module from 3Shape Software
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees)
Measured: through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start21 Oct 2022
- Primary completion21 Apr 2023
- Study completion21 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - AssessmentStudies 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
- Cross-sectional
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Khaled Abd ElAziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019351
- Sponsor's protocol ID
- 711
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT06019351
- Acronym / sponsor ID
- 711
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 31 Aug 2023 (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.
Digital transformation in the orthodontic field profoundly alters the way in which orthodontic treatment is perceived and delivered, moreover it aids in creating individualized orthodontic appliances.A crucial step in digital orthodontic planning in either indirect bonding or aligner treatment is localization of mesiodistal tip. Earlier, Panoramic radiographs were formerly recommended to assist clinicians in properly identifying mesiodistal root angulation. recommended to help clinician to identify mesiodistal root angulation accurately. Owens et al. recorded clinically significant variation between the radiographic and the true root angulation. Alternatively CBCT (Cone Beam Computed Tomography) guided mesiodistal root angulation assessment has superior clinical significance compared to the routinely taken panoramic radiograph . despite its accuracy ,CBCT is not justified as a part of diagnostic records for orthodontic treatment planning following the ALARA rule . To eliminate additional x ray dose Computer aided mesiodistal root angulation identification is provided by several softwares such as OrthoAnalyzer™ ,OrthoCAD® ,and SureSmile® , however, the accuracy remains questionable. These finding may point out the importance of studying the accuracy mesiodistal identification to carry on digital workflow without the radiographic guidance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.
Key inclusion criteria (2 listed)
- Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.
- Justified CBCT record taken for impacted and ectopic teeth, planning for MARPE (mini-screw assisted rapid palatal expansion)/MSE (maxillary skeletal expansion), critical tooth movements in periodontally compromised patients, surgery first cases, taken for previous studies and other reasons.
Key exclusion criteria (3 listed)
- Severe crowding.
- Teeth with bizarre anatomy or severely decayed.
- Patients in mixed dentition stage.
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 |
|---|---|---|
| OrthoAnalyzer™ softwareOrthoAnalyzer™ software module from 3Shape Software | Device | – |
Primary outcome
Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees)
Time frame: through study completion, an average of 1 year".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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 Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - Assessment, 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 2 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 31 Aug 2023. 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?
Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees) (time frame: through study completion, an average of 1 year".). 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 31 Aug 2023.