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Completed

NCT Number: NCT05010616

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

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Fixed orthodontic appliances

Device

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.

Primary outcomes

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

    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

    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.

  2. Change in patient's expectation towards smile improvement

    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

    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.

  3. Change in patient's expectation towards chewing improvement

    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

    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.

  4. Change in patient's expectations towards speech improvement

    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

    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.

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

    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

    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

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

    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

    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.

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

    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

    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.
  8. Changes in patient's satisfaction with teeth appearance

    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

    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

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

    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

    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

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

    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

    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

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

    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

    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

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

    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

    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.

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

    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.

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Influence of Showing Patients the Three-dimensional Digital Simulation of Their Teeth Alignment Produced by Orthodontic Treatment With Fixed Appliance on Their Expectations and Satisfaction

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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