- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648515
Evaluation of the Accuracy of Measurements Made on Images Taken From the Mouth for Dental Arches
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.
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.
Study Overview
Status
Conditions
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 .
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Damascus, Syrian Arab Republic, DM20AM18
- Department of Orthodontics, University of Damascus Dental School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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. |
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:
The dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes.
Other Names:
The poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
|
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.
|
|
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.
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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. Impressions will be taken in the same day of patient's entry to the cohort.
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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. |
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.
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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.
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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. |
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.
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Collaborators and Investigators
Sponsor
Investigators
- 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: Rashad Murad, DDS MSc PhD, Associate Professor of Toxicology, University of Damascus Pharmacological College, Damascus, Syria
Publications and helpful links
General Publications
- Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
- Almasoud N, Bearn D. Little's irregularity index: photographic assessment vs study model assessment. Am J Orthod Dentofacial Orthop. 2010 Dec;138(6):787-94. doi: 10.1016/j.ajodo.2009.01.031.
- Jones ML. The Barry Project--a three-dimensional assessment of occlusal treatment change in a consecutively referred sample: the incisors. Br J Orthod. 1990 Feb;17(1):1-19. doi: 10.1179/bjo.17.1.1.
- Puneky PJ, Sadowsky C, BeGole EA. Tooth morphology and lower incisor alignment many years after orthodontic therapy. Am J Orthod. 1984 Oct;86(4):299-305. doi: 10.1016/0002-9416(84)90140-4.
- Surbeck BT, Artun J, Hawkins NR, Leroux B. Associations between initial, posttreatment, and postretention alignment of maxillary anterior teeth. Am J Orthod Dentofacial Orthop. 1998 Feb;113(2):186-95. doi: 10.1016/s0889-5406(98)70291-4.
- Tran AM, Rugh JD, Chacon JA, Hatch JP. Reliability and validity of a computer-based Little irregularity index. Am J Orthod Dentofacial Orthop. 2003 Mar;123(3):349-51. doi: 10.1067/mod.2003.76. No abstract available.
- West AE, Jones ML, Newcombe RG. Multiflex versus superelastic: a randomized clinical trial of the tooth alignment ability of initial arch wires. Am J Orthod Dentofacial Orthop. 1995 Nov;108(5):464-71. doi: 10.1016/s0889-5406(95)70046-3.
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
- UDDS-Ortho-11-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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