NCT05711160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

January 24, 2023

Last Update Submit

November 27, 2023

Conditions

Keywords

plaster modelcone beam computed tomography.intraoral scannerteeth widthsBolton' ratios.CBCTIOS

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

Study Arms (1)

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.

Diagnostic Test: Plaster modelsDiagnostic Test: CBCT imagesDiagnostic Test: IOS images

Interventions

Plaster modelsDIAGNOSTIC_TEST

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.

Also known as: Study models, Study casts, Poured study models
Malocclusion patients
CBCT imagesDIAGNOSTIC_TEST

All patients have been undergoing CBCT scans for both jaws

Also known as: cone beam computed tomography images.
Malocclusion patients
IOS imagesDIAGNOSTIC_TEST

The patient's teeth have been dried with air syringe and scanned with the Intraoral scanner

Also known as: intra oral scanner images
Malocclusion patients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with different levels of malocclusion

You may qualify if:

  • 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.

You may not qualify if:

  • 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/

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamad Radwan Sirri

Duhok, Iraq

Location

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director-Iraq-Duhok

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

October 10, 2021

Primary Completion

June 29, 2022

Study Completion

December 25, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations