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

Sponsor
Damascus University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05010616
Collaborator
(none)
25
1
1
16
1.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fixed orthodontic appliances
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Jun 5, 2022
Anticipated Study Completion Date :
Nov 5, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Orthodontics, University of Damascus Dental School Damascus Syrian Arab Republic

Sponsors and Collaborators

  • Damascus University

Investigators

  • Principal Investigator: Abd Alrahman Qusaibati, DDS, MSc student at the Orthodontic Department, University of Damascus Dental
  • Study Chair: Kinda sultan, DDS,MSc,PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT05010616
Other Study ID Numbers:
  • UDDS-Ortho-07-2021
First Posted:
Aug 18, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021