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

Crowding, Tooth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010616
• Other study ID #: UDDS-Ortho-07-2021
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: November 5, 2022

Study information

• Verified date: November 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding, Tooth
• Malocclusion

Intervention

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.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

Grünheid 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.