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Evaluation of the Accuracy of Measurements Made on Images Taken From the Mouth for Dental Arches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648515
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

The general trend in the orthodontic practice is to become digital in many aspects. Since 1980s, digital photographs have been available and they play a principal role in the orthodontic practice for documentation and diagnosis purposes. Now photographs have an important role in teaching, scientific research and medical examination.

Successful orthodontic treatment is based on a comprehensive diagnosis and treatment planning. A few of the fundamental factors in the diagnosis are the spacing condition, tooth size, arch form and dimensions, as well as the tooth-arch discrepancies. Intraoral photographs' major role is to enable orthodontists to document and analyze the occlusal relationships as well as the dental and soft-tissue features in order to arrive at a good diagnosis and an appropriate treatment plan.

In 1975, Robert Little developed Little's irregularity index (LII). The index was proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements was the LII score. The higher the index value, the more severe irregularity of the teeth was. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity

Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone. Bolton analysis is another important measurement 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 formulas, the overall ratio should be 91.3% (±1.91) and the partial (anterior) ratio should be 77.2% (±1.65).

The validity and reliability of performing the above mentioned analyses on images taken of the dental arches have not been evaluated yet in the literature. This is the aim of the current project.


Condition or disease Intervention/treatment
Malocclusion Diagnostic Test: Plaster models Diagnostic Test: Digital Images of the dental arches Diagnostic Test: Digital images of models

Detailed Description:

Assessment of the LII scores, TSALD, Bolton analysis has been performed by the majority of previous studies using plaster models and calipers in a direct manner. Others have measured previous variables indirectly using 2-dimensional and 3-dimensional (3D) methods. 2D methods have included 2D scans of plaster models or 2D images of the occlusal views. The obtained images have been then analyzed either manually or on-screen using dedicated software. 3D methods have included digital models and have been used by several researchers. Although the wealth of knowledge 3D methods provide, they require the use of 3D imaging techniques with the resultant additional costs, time and labor.

Many studies have used 2D digital images of poured plaster models to perform software-based measurements of tooth movement during active treatment but these studies have not reported the accuracy and reproducibility of their methods. Dental impressions have been required to obtain proper study models. This procedure is a time- and labor-consuming for the orthodontist and could be exhausting to the patient. When braces are fitted, impression taking becomes a difficult task and if several impressions are required in the context of a research project, this would impose additional burden to patients and researchers. Therefore, taking intra-oral images of dental arches instead of impressions seems to be a very convenient alternative.

Validity and reliability of measurements made on photographs of study models have been evaluated in previous reports. However, it seems to be that there is only one paper in the literature with the aim of validating the use of intra-oral images of the dental arches for performing dental measurement. They found that the analysis of LII was valid. However, the practicability of their suggested method of imaging was questionable and their evaluation was only confined to the LII, which is not the only variable that is used in our ordinary plaster model analysis.

Therefore, the primary aim of the current work were to evaluate the validity and reliability of measurements made directly on intraoral photographs compared to those made on poured plaster models in the assessment of the LII, TSALD, and Bolton ratios. As a secondary aim, the comparisons were also accomplished with those measurements made on photographs taken of the corresponding poured plaster models .

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Validity and Reliability of Measurements Made on Intra-oral Images of the Dental Arches Compared to Those Made on Poured Plaster Models in the Assessment of Tooth-size-arch-length-discrepancy, Bolton's Analysis and Little's Index of Irregularity.
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : August 19, 2018
Actual Study Completion Date : September 15, 2018

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.

Then, digital images of the dental arches of each patient will be taken using a dedicated camera with very high resolution. Finally, digital images of models that were poured with gypsum will be taken also with the same camera and in the same conditions.

Diagnostic Test: 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:
  • Study models
  • Study casts
  • Poured study models

Diagnostic Test: Digital Images of the dental arches
The dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes.
Other Name: Intra-oral images

Diagnostic Test: Digital images of models
The poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes.




Primary Outcome Measures :
  1. Little's Index of Irregularity (LII) [ Time Frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort. ]
    Robert Little developed Little's irregularity index (LII) in 1975. The index has been proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements is considered the LII score. The higher the index value, the more severe irregularity of the teeth is. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity.

  2. Partial Bolton's Ratio [ Time Frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort. ]

    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.


  3. Overall Bolton's Ratio [ Time Frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort. ]

    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.


  4. Tooth-size-arch-length-discrepancy (TSALD) [ Time Frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort. ]

    Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone.

    The formula is The sum of mesio-distal widths of all permanent teeth (mesial to the first lower/upper molars) minus the sum of the basal bone length (measured by a specific thread). The result is expressed in mm.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with different levels of malocclusion
Criteria

Inclusion Criteria:

  • Complete permanent dentition
  • Absence of any big carious lesions
  • Absence of fixed prosthodontics (fixed bridges)
  • Absence of shape and size disturbances (regardless third molar)
  • Presence of upper and lower crowded arches

Exclusion Criteria: (fixed br

  • Missing teeth
  • Migrated teeth
  • Impacted teeth
  • Severely broken down teeth or big carious lesions
  • Presence of fixed prosthodontics (fixed bridges)
  • Presence of shape and size disturbances

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648515


Locations
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Syrian Arab Republic
Department of Orthodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Wael Al-Rasheed Omer, DDS MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Principal Investigator: Amer M Owayda, DDS MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA
Study Director: Mohammad Y Hajeer, DDS MSc PhD Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, SYRIA
Study Director: Rashad Murad, DDS MSc PhD Associate Professor of Toxicology, University of Damascus Pharmacological College, Damascus, Syria

Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03648515    
Other Study ID Numbers: UDDS-Ortho-11-2018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Damascus University:
Validity
Reliability
Reproducibility
Intra-oral images
Plaster models
Digital images
Little's index of irregularity
Bolton's analysis
Tooth-size-arch-length-discrepancy
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases