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

NCT05010616 | Completed DMC

• 1 other identifier: UDDS-Ortho-07-2021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Crowding, Tooth

Keywords

Crowding; Simulation; Prediction; Expectation; Satisfaction; Three-dimensional set up

Outcome Measures

Primary Outcomes (13)

• 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.

  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

• 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.

  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

• 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.

  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

• 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.

  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

• 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

  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

• 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.

  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

• 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.

  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

• 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

  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

• 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

  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

• 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

  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

• 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

  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

• 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.

  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

• 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.

  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.

Study Arms (1)

Three-dimensional digital simulation with fixed appliance

EXPERIMENTAL

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

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.

Three-dimensional digital simulation with fixed appliance

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 28686090 BACKGROUND

• 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.

  PMID: 31784021 BACKGROUND

• 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.

  PMID: 32110468 BACKGROUND

• 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.

  PMID: 12490870 BACKGROUND

• 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.

  PMID: 25372019 BACKGROUND

• Kusaibati AM, Sultan K, Hajeer MY, Burhan AS, Alam MK. Adult patient expectations and satisfaction: Can they be influenced by viewing the three-dimensional predicted outcome before fixed orthodontic treatment of dental crowding? J World Fed Orthod. 2023 Dec;12(6):269-279. doi: 10.1016/j.ejwf.2023.08.005. Epub 2023 Sep 28.

  PMID: 37777351 DERIVED

MeSH Terms

Conditions

Malocclusion; Crowding; Personal Satisfaction

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Abd Alrahman Qusaibati, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental

  PRINCIPAL INVESTIGATOR

• Kinda sultan, DDS,MSc,PhD

  Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: July 5, 2021
• Primary Completion: June 5, 2022
• Study Completion: November 5, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)