NCT03648515

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

June 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

August 24, 2018

Last Update Submit

July 16, 2019

Conditions

Keywords

ValidityReliabilityReproducibilityIntra-oral imagesPlaster modelsDigital imagesLittle's index of irregularityBolton's analysisTooth-size-arch-length-discrepancy

Outcome Measures

Primary Outcomes (4)

  • Little's Index of Irregularity (LII)

    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

    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.

  • Overall Bolton's Ratio

    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.

  • Tooth-size-arch-length-discrepancy (TSALD)

    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.

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. 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 modelsDiagnostic Test: Digital Images of the dental archesDiagnostic Test: Digital images of models

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

The dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes.

Also known as: Intra-oral images
Malocclusion patients

The poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes.

Malocclusion patients

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with different levels of malocclusion

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (7)

  • 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.

    PMID: 21130338BACKGROUND
  • 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.

    PMID: 2310735BACKGROUND
  • 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.

    PMID: 1059332BACKGROUND
  • 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.

    PMID: 6592978BACKGROUND
  • 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.

    PMID: 9484210BACKGROUND
  • 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.

    PMID: 12637908BACKGROUND
  • 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.

    PMID: 7484965BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2018

First Posted

August 27, 2018

Study Start

June 15, 2018

Primary Completion

August 19, 2018

Study Completion

September 15, 2018

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations