MalocclusionNCT05711160
Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
An observational study of Malocclusion, run by University of Duhok at 1 site in Iraq.
Trial summary
The orthodontist uses plaster models to collect information. This includes identification deviations, classification of malocclusion, formulation of treatment goals for specific patient. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Plaster models, CBCT images and IOS images
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 51 participants
- Where
- 1 siteIraq
- Study dates
- 10 Oct 2021to 25 Dec 2022
- How long will I take part?
- 6 Months
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with different levels of malocclusion
Who may be able to join
- Age between 18 and 35 years.
- Full permanent dentition from right first molar to left first molar in both upper and lower arches.
- Participants should not be under orthodontic treatment.
Who cannot join
- Tooth agenesis or extractions.
- Presence of large restorations that could change the mesiodistal diameters of the teeth.
- Teeth with anomalous shapes.
- Teeth with large carious lesions.
- Enamel defects that affect the morphology of crown.
- Severe crowding in the dentition (< 6 mm).
- Missing or heavily restored teeth.
- Teeth with large carious lesions / enamel defects that affect the morphology of crown/
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy and Reliability of Teeth Widths and Bolton' Ratios Measured in Cone-Beam Computer Tomography and Intra Oral Scanner Images Compared With Plaster Models (Gold Standard) in a Sample of Duhok Population.
The orthodontist uses plaster models to collect information. This includes identification deviations, classification of malocclusion, formulation of treatment goals for specific patient. Models are used to examine the morphology of individual teeth and also to visualize the placement of teeth in individual dental arches. Study models It therefore appears to be one of the most important records for treatment planning.
In USA, orthodontist can start practicing orthodontics which requires a lot of difficulty 300 new cases in a year and therefore may require an entire room to store plaster models. The minimum file retention period depends on the appropriate platform for the statute of limitations during which legal action for fault can be brought. in the USA, this time period varies from 5 to 15 years, varies from country to country.
Read more
This platform can be started on the last day of treatment, or it can be postponed until the patient reaches adulthood. Regardless of how it is viewed, long term storage is required. Over ten years, if 300 new cases are initiated each year, that will represent 6,000 combinations of prototyping, pre-processing and post-processing. Additional storage space may be required, maybe somewhere else, with financial implications.
With the recent introduction of digital models and CBCT images, the orthodontist now has an alternative to traditional plaster study models. Digital technology makes it possible to analyze a computer using software capable of rotating, examining and measuring digital images of the model and dental arches from different points of view. The intraoral scanner is a hand-held device that creates digital impressions of the oral fossa and displays it in 3D on a computer screen after being processed by the scanning program for each device. By 1985 the first intraoral scanner was available for commercial use, and over time it had evolved to become smaller, faster, and more accurate. Intraoral scanners provide easier treatment planning, better workflow, greater patient acceptance and shorter working time, but more studies are needed to investigate their accuracy and compare with traditional methods. The measurements of the tooth widths are one of the important elements in orthodontic diagnosis because of its role in calculating the partial and total Bolton ratio, the Ton relationship, and space analysis. Therefore, the aim of this study will be to assess the accuracy and reliability of measuring teeth widths and Bolton ratios based on three mains well -known methods (plaster models, CBCT images and intraoral images) to ensure the safety of orthodontic diagnostic outputs.
Read the detailed description
Several published studies analyzed teeth widths and Bolton' ratios using CBCT with plaster models, two-dimensional images, or three-dimensional images as the gold standard and applied to patients or skulls, but they did not use the sagittal axis orientation method for each tooth on the limit to determine its precise lateral mesial width, but the method of unified orientation was adopted in the transverse plane.
The most important benefit of the CBCT is that the measurements are made directly on the digital model, which eliminates the possibility of error that can occur with traditional methods (alginate blending, alginate hardening, casting) or some other digital methods (such as scanning plaster model).
The special orientation method was adopted for each tooth separately so that the three axes of the software are perpendicular to the longitudinal axis of the tooth, and the maximum mesio-lateral width is determined on both the axial plane and the transverse plane, and the measurement is made on each of them, which is supposed to be identical in the case of correct orientation.
This method is useful for determining the width of each tooth, regardless of its position within the dental arch or overlapping it with other teeth.
The intraoral scan is the latest innovation in dentistry to generate three-dimensional models that can be studied, and many tests were conducted on it to determine its accuracy and reliability by determining teeth widths and the Bolton ratios with the adoption of plaster models or two-dimensional images as a gold standard.
Looking at the published medical literature, and in an attempt to find a study similar to the current study, It was found that the comparisons regarding teeth widths measurements were among plaster models (as a gold standard) and CBCT images or between plaster models (as a gold standard) and IOS images, and no study was found that made a comparison Triple among the previous three methods.
- Conditions
- Malocclusion
- Being tested
- Plaster models, CBCT images, IOS images
- Keywords
- plaster model, cone beam computed tomography., intraoral scanner, teeth widths, Bolton' ratios., CBCT, IOS
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster modelsDiagnostic test
Also called Study models, Study casts, Poured study models
The impressions taken of the dental arches will be poured with hard gypsum in order to make use of the models for taking measurements. These measurements will be considered the gold standard.
CBCT imagesDiagnostic test
Also called cone beam computed tomography images.
All patients have been undergoing CBCT scans for both jaws
IOS imagesDiagnostic test
Also called intra oral scanner images
The patient's teeth have been dried with air syringe and scanned with the Intraoral scanner
| Study group | Role | What they receive |
|---|---|---|
| Malocclusion patients | Patients with different types of malocclusion will be included. Plaster models will be fabricated after pouring the impressions with hard gypsum.
All patients have been undergoing CBCT scans for both jaws. Then, intraoral scanned of the dental arches of each patient have been taken using an intraoral scanner. Then measurements were made on digital images (CBCT \& IOS) and on plaster models. Receives: Diagnostic Test: Plaster models; Diagnostic Test: CBCT images; Diagnostic Test: IOS images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth width using plaster models.
Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact areas when the teeth will correctly align using a digital electronic caliper. The result is expressed in mm.
Measured: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Tooth width using CBCT images.
For the anterior teeth: (centrals, laterals and canines) On the cross section \& frontal section: Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point.
The result is expressed in mm. For the posterior teeth: (premolars and first molars) On the cross section \& sagittal section: Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point.
The result is expressed in mm. This method was adopted to obtain the true width of each tooth, regardless of its position within the dental arch.
Measured: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
Tooth width using IOS images.
Digital images have been opened in the software, and Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point using the "Diagnostics" tool.
Measured: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Anterior Bolton' ratio using plaster models.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Measured: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Anterior Bolton' ratio using CBCT images.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Measured: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
Anterior Bolton' ratio using IOS images.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Measured: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Overall Bolton' ratio using plaster models.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Measured: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Overall Bolton' ratio using CBCT images.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Measured: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
Overall Bolton' ratio using IOS images.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Measured: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start10 Oct 2021
- Primary completion29 Jun 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Duhok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Radwan Sirri, University of Duhok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711160
- Sponsor's protocol ID
- SL1990
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim J, Lagravere MO. Accuracy of Bolton analysis measured in laser scanned digital models compared with plaster models (gold standard) and cone-beam computer tomography images. Korean J Orthod. 2016 Jan;46(1):13-9. doi: 10.4041/kjod.2016.46.1.13. Epub 2016 Jan 25.
PubMed 26877978Paredes V, Gandia JL, Cibrian R. Determination of Bolton tooth-size ratios by digitization, and comparison with the traditional method. Eur J Orthod. 2006 Apr;28(2):120-5. doi: 10.1093/ejo/cji077. Epub 2005 Dec 22.
PubMed 16373454Wiranto MG, Engelbrecht WP, Tutein Nolthenius HE, van der Meer WJ, Ren Y. Validity, reliability, and reproducibility of linear measurements on digital models obtained from intraoral and cone-beam computed tomography scans of alginate impressions. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):140-7. doi: 10.1016/j.ajodo.2012.06.018.
PubMed 23273370Kumar AA, Phillip A, Kumar S, Rawat A, Priya S, Kumaran V. Digital model as an alternative to plaster model in assessment of space analysis. J Pharm Bioallied Sci. 2015 Aug;7(Suppl 2):S465-9. doi: 10.4103/0975-7406.163506.
PubMed 26538899Alam MK, Shahid F, Purmal K, Ahmad B, Khamis MF. Bolton tooth size ratio and its relation with arch widths, arch length and arch perimeter: a cone beam computed tomography (CBCT) study. Acta Odontol Scand. 2014 Nov;72(8):1047-53. doi: 10.3109/00016357.2014.946967. Epub 2014 Sep 15.
PubMed 25220521
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Reliability of Teeth Widths and Bolton' Ratios Measured in Cone-Beam Computer Tomography and Intra Oral Scanner Images Compared With Plaster Models (Gold Standard) in a Sample of Duhok Population.
- ClinicalTrials.gov ID
- NCT05711160
- Acronym / sponsor ID
- SL1990
- Conditions
- Malocclusion
- Keywords
- plaster model, cone beam computed tomography., intraoral scanner, teeth widths, Bolton' ratios., CBCT, IOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of DuhokUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 2 Feb 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.
The orthodontist uses plaster models to collect information. This includes identification deviations, classification of malocclusion, formulation of treatment goals for specific patient. Models are used to examine the morphology of individual teeth and also to visualize the placement of teeth in individual dental arches. Study models It therefore appears to be one of the most important records for treatment planning.
In USA, orthodontist can start practicing orthodontics which requires a lot of difficulty 300 new cases in a year and therefore may require an entire room to store plaster models. The minimum file retention period depends on the appropriate platform for the statute of limitations during which legal action for fault can be brought. in the USA, this time period varies from 5 to 15 years, varies from country to country.
This platform can be started on the last day of treatment, or it can be postponed until the patient reaches adulthood. Regardless of how it is viewed, long term storage is required. Over ten years, if 300 new cases are initiated each year, that will represent 6,000 combinations of prototyping, pre-processing and post-processing. Additional storage space may be required, maybe somewhere else, with financial implications.
With the recent introduction of digital models and CBCT images, the orthodontist now has an alternative to traditional plaster study models. Digital technology makes it possible to analyze a computer using software capable of rotating, examining and measuring digital images of the model and dental arches from different points of view. The intraoral scanner is a hand-held device that creates digital impressions of the oral fossa and displays it in 3D on a computer screen after being processed by the scanning program for each device. By 1985 the first intraoral scanner was available for commercial use, and over time it had evolved to become smaller, faster, and more accurate. Intraoral scanners provide easier treatment planning, better workflow, greater patient acceptance and shorter working time, but more studies are needed to investigate their accuracy and compare with traditional methods. The measurements of the tooth widths are one of the important elements in orthodontic diagnosis because of its role in calculating the partial and total Bolton ratio, the Ton relationship, and space analysis. Therefore, the aim of this study will be to assess the accuracy and reliability of measuring teeth widths and Bolton ratios based on three mains well -known methods (plaster models, CBCT images and intraoral images) to ensure the safety of orthodontic diagnostic outputs.
Detailed description
Several published studies analyzed teeth widths and Bolton' ratios using CBCT with plaster models, two-dimensional images, or three-dimensional images as the gold standard and applied to patients or skulls, but they did not use the sagittal axis orientation method for each tooth on the limit to determine its precise lateral mesial width, but the method of unified orientation was adopted in the transverse plane.
The most important benefit of the CBCT is that the measurements are made directly on the digital model, which eliminates the possibility of error that can occur with traditional methods (alginate blending, alginate hardening, casting) or some other digital methods (such as scanning plaster model).
The special orientation method was adopted for each tooth separately so that the three axes of the software are perpendicular to the longitudinal axis of the tooth, and the maximum mesio-lateral width is determined on both the axial plane and the transverse plane, and the measurement is made on each of them, which is supposed to be identical in the case of correct orientation.
This method is useful for determining the width of each tooth, regardless of its position within the dental arch or overlapping it with other teeth.
The intraoral scan is the latest innovation in dentistry to generate three-dimensional models that can be studied, and many tests were conducted on it to determine its accuracy and reliability by determining teeth widths and the Bolton ratios with the adoption of plaster models or two-dimensional images as a gold standard.
Looking at the published medical literature, and in an attempt to find a study similar to the current study, It was found that the comparisons regarding teeth widths measurements were among plaster models (as a gold standard) and CBCT images or between plaster models (as a gold standard) and IOS images, and no study was found that made a comparison Triple among the previous three methods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malocclusion patients | – | Diagnostic Test: Plaster models, Diagnostic Test: CBCT images, Diagnostic Test: IOS imagesPatients with different types of malocclusion will be included. Plaster models will be fabricated after pouring the impressions with hard gypsum. All patients have been undergoing CBCT scans for both jaws. Then, intraoral scanned of the dental arches of each patient have been taken using an intraoral scanner. Then measurements were made on digital images (CBCT \& IOS) and on plaster models. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with different levels of malocclusion
Key inclusion criteria (3 listed)
- Age between 18 and 35 years.
- Full permanent dentition from right first molar to left first molar in both upper and lower arches.
- Participants should not be under orthodontic treatment.
Key exclusion criteria (8 listed)
- Tooth agenesis or extractions.
- Presence of large restorations that could change the mesiodistal diameters of the teeth.
- Teeth with anomalous shapes.
- Teeth with large carious lesions.
- Enamel defects that affect the morphology of crown.
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 |
|---|---|---|
| Plaster modelsAlso: Study models, Study casts, Poured study modelsThe impressions taken of the dental arches will be poured with hard gypsum in order to make use of the models for taking measurements. These measurements will be considered the gold standard. | Diagnostic test | Malocclusion patients |
| CBCT imagesAlso: cone beam computed tomography images.All patients have been undergoing CBCT scans for both jaws | Diagnostic test | Malocclusion patients |
| IOS imagesAlso: intra oral scanner imagesThe patient's teeth have been dried with air syringe and scanned with the Intraoral scanner | Diagnostic test | Malocclusion patients |
Primary outcome
Tooth width using plaster models.
Time frame: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact areas when the teeth will correctly align using a digital electronic caliper. The result is expressed in mm.
Tooth width using CBCT images.
Time frame: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
For the anterior teeth: (centrals, laterals and canines) On the cross section \& frontal section: Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point. The result is expressed in mm. For the posterior teeth: (premolars and first molars) On the cross section \& sagittal section: Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point. The result is expressed in mm. This method was adopted to obtain the true width of each tooth, regardless of its position within the dental arch.
Tooth width using IOS images.
Time frame: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Digital images have been opened in the software, and Maximum mesiodistal width of each crown (from the first molar to the first molar of each jaw) has been measured between the anatomic contact point using the "Diagnostics" tool.
Anterior Bolton' ratio using plaster models.
Time frame: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Anterior Bolton' ratio using CBCT images.
Time frame: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Anterior Bolton' ratio using IOS images.
Time frame: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Overall Bolton' ratio using plaster models.
Time frame: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Overall Bolton' ratio using CBCT images.
Time frame: After seven days of taking the CBCT scans for both jaws. CBCT images have been taken in the same day of patient's entry to the study.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Overall Bolton' ratio using IOS images.
Time frame: After seven days of scanned with the Intraoral scanner for both jaws. IOS images have been taken in the same day of patient's entry to the study
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Results publication: PubMed 26877978Kim J, Lagravere MO. Accuracy of Bolton analysis measured in laser scanned digital models compared with plaster models (gold standard) and cone-beam computer tomography images. Korean J Orthod. 2016 Jan;46(1):13-9. doi: 10.4041/kjod.2016.46.1.13. Epub 2016 Jan 25.
- Results publication: PubMed 16373454Paredes V, Gandia JL, Cibrian R. Determination of Bolton tooth-size ratios by digitization, and comparison with the traditional method. Eur J Orthod. 2006 Apr;28(2):120-5. doi: 10.1093/ejo/cji077. Epub 2005 Dec 22.
- Results publication: PubMed 23273370Wiranto MG, Engelbrecht WP, Tutein Nolthenius HE, van der Meer WJ, Ren Y. Validity, reliability, and reproducibility of linear measurements on digital models obtained from intraoral and cone-beam computed tomography scans of alginate impressions. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):140-7. doi: 10.1016/j.ajodo.2012.06.018.
- Results publication: PubMed 26538899Kumar AA, Phillip A, Kumar S, Rawat A, Priya S, Kumaran V. Digital model as an alternative to plaster model in assessment of space analysis. J Pharm Bioallied Sci. 2015 Aug;7(Suppl 2):S465-9. doi: 10.4103/0975-7406.163506.
- Results publication: PubMed 25220521Alam MK, Shahid F, Purmal K, Ahmad B, Khamis MF. Bolton tooth size ratio and its relation with arch widths, arch length and arch perimeter: a cone beam computed tomography (CBCT) study. Acta Odontol Scand. 2014 Nov;72(8):1047-53. doi: 10.3109/00016357.2014.946967. Epub 2014 Sep 15.
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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?
An observational study of Malocclusion, run by University of Duhok at 1 site in Iraq.
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 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: finished, as of the sponsor's last update on 28 Nov 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tooth width using plaster models. (time frame: After seven days of taking the impressions of the dental arches. Silicon Impressions have been taken in the same day of patient's entry to the study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711160, which also lists 5 linked publications.
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 28 Nov 2023.