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

Primary Purpose

Crowding, Tooth

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Fixed orthodontic appliances

About this trial

This is an interventional treatment trial for Crowding, Tooth focused on measuring Crowding, Simulation, Prediction, Expectation, Satisfaction, Three-dimensional set up

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Three-dimensional digital simulation with fixed appliance

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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

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.

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.

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

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

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

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05010616

First Posted

August 11, 2021

Last Updated

November 11, 2022

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT05010616

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 5, 2021 (Actual)

Primary Completion Date

June 5, 2022 (Actual)

Study Completion Date

November 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crowding, Tooth

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Three-dimensional digital simulation with fixed appliance

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Fixed orthodontic appliances

Intervention Description

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 Outcome Measure Information:

Title

Change in patient's expectation towards teeth alignment:

Description

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

Title

Change in patient's expectation towards smile improvement

Description

Time Frame

Title

Change in patient's expectation towards chewing improvement

Description

Time Frame

Title

Change in patient's expectations towards speech improvement

Description

Time Frame

Title

Change in patient's expectations towards oral hygiene improvement

Description

Time Frame

Title

Change in patient's expectations towards getting a better career

Description

Time Frame

Title

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

Description

Time Frame

Title

Changes in patient's satisfaction with teeth appearance

Description

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

Title

Changes in patient's satisfaction with frontal teeth relationship

Description

Time Frame

Title

Changes in patient's satisfaction level with teeth alignment

Description

Time Frame

Title

Changes in patient's satisfaction level with teeth engagement

Description

Time Frame

Title

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

Description

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

Title

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

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abd Alrahman Qusaibati, DDS

Organizational Affiliation

MSc student at the Orthodontic Department, University of Damascus Dental

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kinda sultan, DDS,MSc,PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Orthodontics, University of Damascus Dental School

City

Damascus

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28686090

Citation

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.

Results Reference

background

PubMed Identifier

31784021

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.

Results Reference

background

PubMed Identifier

32110468

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.

Results Reference

background

PubMed Identifier

12490870

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. doi: 10.1067/mod.2002.128213.

Results Reference

background

PubMed Identifier

25372019

Citation

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.

Results Reference

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

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