- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05711160
Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Duhok, Iraq
- Mohamad Radwan Sirri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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/
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
Other Names:
All patients have been undergoing CBCT scans for both jaws
Other Names:
The patient's teeth have been dried with air syringe and scanned with the Intraoral scanner
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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
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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.
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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. |
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.
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
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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.
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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
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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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Paredes 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.
- Wiranto 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.
- Kumar 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.
- Alam 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SL1990
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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