CClinicalTrials.gg
CompletedNCT05010616Updated Nov 14, 2022

Evaluating the Influence of Showing Patients Their Predicted Teeth Alignment on Their Expectations and Satisfaction

An interventional study of Fixed orthodontic appliances in Crowding, Tooth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 24 Years
Sex
All
01

Study summary

Patients who have moderate crowding will be treated in this study. The efficacy of showing the predicted alignment of patient's teeth at the end of orthodontic treatment previously to treatment on their expectations from orthodontic treatment and their satisfaction with their teeth alignment will be assessed.

Read the detailed description

It is known that most patients expect that orthodontic treatment will improve their appearance which increases their confidence and self-esteem level.

The ability to approach patient's expectations to reality is crucial to making them reasonable and to improve patient's satisfaction with treatment outcomes.

02

Conditions studied

  • Crowding, Tooth

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Keywords

  • Crowding
  • Simulation
  • Prediction
  • Expectation
  • Satisfaction
  • Three-dimensional set up
03

In context

Malocclusion

455 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 25 is below the median of 36 across 371 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Class I malocclusion with moderate crowding (between 4-6 mm of tooth-size-arch-length-discrepancy).
  • Good oral hygiene and periodontal health.
  • No severe skeletal discrepancy.
  • Normal proclination for the upper and lower incisors.

Exclusion criteria

Exclusion Criteria:

  • Bimaxillary dentoalveolar severe protrusion.
  • Need for extraction.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • congenitally missing or extracted teeth (except for the third molars).
  • history of previous trauma to the maxillofacial region or surgical interventions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Three-dimensional digital simulation with fixed appliance

    The records will be obtained at the first visit, which will be one week before placing brackets. At the second visit, the orthodontic appliances will be applied; then assessments will be taken after 15 minutes of showing the patient the digital simulation of their teeth alignment at the end of orthodontic treatment.

    Device: Fixed orthodontic appliances

Interventions

  • DeviceFixed orthodontic appliances

    Visual presentation of patient's predicted teeth alignment at the end of orthodontic treatment: Presenting predicted teeth alignment after orthodontic treatment to patients before treatment starts, by using photos and videos of dental digital set-up. Predicted teeth alignment can be described as: well-leveled and aligned patient's dental arches, well engaged posterior teeth and normal frontal teeth relationships.

06

What researchers measure

Primary outcomes

  1. Change in patient's expectation towards teeth alignment:

    Patients will be asked: Do you expect the orthodontic treatment to straighten your teeth? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  2. Change in patient's expectation towards smile improvement

    Patients will be asked: Do you expect the orthodontic treatment to produce a better smile? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  3. Change in patient's expectation towards chewing improvement

    Patients will be asked: Do you expect the orthodontic treatment to make it easier to eat? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  4. Change in patient's expectations towards speech improvement

    Patients will be asked: Do you expect the orthodontic treatment to make it easier to speak? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  5. Change in patient's expectations towards oral hygiene improvement

    Patients will be asked: Do you expect the orthodontic treatment to make it easier to keep your teeth clean? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  6. Change in patient's expectations towards getting a better career

    Patients will be asked: Do you expect the orthodontic treatment to improve your chance of a good career? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  7. Change in patient's expectations towards getting a better social confidence

    Patients will be asked: Do you expect the orthodontic treatment to give you confidence socially? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not expected. Grades 1-3 = less expected. Grades 4-6 = average expected. Grades 7-9 = highly expected. Grade 10 = most expected. Scores of questions 1-2-3-4-5-6-7 will be summed to obtain total expectation's score. Questionnaires applied by patients at (T0) and (T1) will be compared by: * Comparing each question individually between T0 and T1. * Comparing questionnaire's overall score between T0 and T1.

    Time frame: T0: 1 week before placing brackets, T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  8. Changes in patient's satisfaction with teeth appearance

    Patients will be asked: Are you satisfied with your teeth appearance? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied

    Time frame: T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment, T2: at the end of treatment after removing brackets

  9. Changes in patient's satisfaction with frontal teeth relationship

    Patients will be asked: express your satisfaction with your frontal teeth relationship? Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied

    Time frame: T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment, T2: at the end of treatment after removing brackets

  10. Changes in patient's satisfaction level with teeth alignment

    Patients will be asked: express your satisfaction with teeth alignment. Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied

    Time frame: T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment, T2: at the end of treatment after removing brackets

  11. Changes in patient's satisfaction level with teeth engagement

    Patients will be asked: express your satisfaction with teeth engagement. Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied

    Time frame: T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment, T2: at the end of treatment after removing brackets

  12. Patient's overall satisfaction level with his teeth alignment following checking the predicated plan

    Patients will be asked: express your overall satisfaction with your teeth after watching your predicted teeth alignment. Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied.

    Time frame: T1: patient's second visit to clinician to begin the orthodontic treatment and after 15 minutes of showing patient the digital simulation of their teeth alignment at the end of orthodontic treatment

  13. Patient's overall satisfaction with his teeth at the end of orthodontic treatment

    Question will be answered on paper using the Visual Analogue Scale (VAS) with grades from 0 to 10. Grade 0 = not satisfied. Grades 1-3 = less satisfied. Grades 4-6 = average satisfaction. Grades 7-9 = highly satisfied. Grade 10 = most satisfied Scores of questions 7-8-9-10-11-12 will be summed to obtain total expected satisfaction's score. Scores of questions 7-8-9-10-11-13 will be summed to obtain total eventual satisfaction's score. Questionnaires applied by patients at (T1) and (T2) will be compared by: * Comparing each question individually between T1 and T2. * Comparing questionnaire's overall score between T1 and T2.

    Time frame: T2:at the end of orthodontic treatment after removing brackets] Patients will be asked: express your overall satisfaction with your teeth at the end of treatment.

07

Study locations

1 site
  • Department of Orthodontics, University of Damascus Dental School
    Damascus, Syrian Arab Republic
08

References and documents

Publications

  • Grunheid T, Loh C, Larson BE. How accurate is Invisalign in nonextraction cases? Are predicted tooth positions achieved? Angle Orthod. 2017 Nov;87(6):809-815. doi: 10.2319/022717-147.1. Epub 2017 Jul 7. PubMed 28686090 ↗
  • Hadadpour S, Noruzian M, Abdi AH, Baghban AA, Nouri M. Can 3D imaging and digital software increase the ability to predict dental arch form after orthodontic treatment? Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):870-877. doi: 10.1016/j.ajodo.2019.07.009. PubMed 31784021 ↗
  • Izhar A, Singh G, Goyal V, Singh R, Gupta N, Pahuja P. Comparative Assessment of Clinical and Predicted Treatment Outcomes of Clear Aligner Treatment: An in Vivo Study. Turk J Orthod. 2019 Dec 1;32(4):229-235. doi: 10.5152/TurkJOrthod.2019.19019. eCollection 2019 Dec. PubMed 32110468 ↗
  • Noroozi H, Djavid GE, Moeinzad H, Teimouri AP. Prediction of arch perimeter changes due to orthodontic treatment. Am J Orthod Dentofacial Orthop. 2002 Dec;122(6):601-7. doi: 10.1067/mod.2002.128213. PubMed 12490870 ↗
  • Buschang PH, Ross M, Shaw SG, Crosby D, Campbell PM. Predicted and actual end-of-treatment occlusion produced with aligner therapy. Angle Orthod. 2015 Sep;85(5):723-7. doi: 10.2319/043014-311.1. Epub 2014 Nov 5. PubMed 25372019 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05010616
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Aug 18, 2021
Start date
Jul 5, 2021
Primary completion
Jun 5, 2022
Completion
Nov 5, 2022
Last update
Nov 14, 2022

Study contacts

Abd Alrahman Qusaibati, DDS
principal investigator · MSc student at the Orthodontic Department, University of Damascus Dental
Kinda sultan, DDS,MSc,PhD
study chair · Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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