Crowding, ToothNCT05010616
Evaluating the Influence of Showing Patients Their Predicted Teeth Alignment on Their Expectations and Satisfaction
A study testing Fixed orthodontic appliances in people with Crowding, Tooth, run by Damascus University at 1 site in Syria.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Crowding, Tooth
- What is being tested?
- Fixed orthodontic appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSyria
- Study dates
- 5 Jul 2021to 5 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus
About this study
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
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.
Read the 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.
- Conditions
- Crowding, Tooth
- Being tested
- Fixed orthodontic appliances
- Keywords
- Crowding, Simulation, Prediction, Expectation, Satisfaction, Three-dimensional set up
- Medical subject headings
- Malocclusion, Crowding, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed orthodontic appliancesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fixed orthodontic appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start5 Jul 2021
- Primary completion5 Jun 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crowding, ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abd Alrahman Qusaibati, DDS, Principal investigator, MSc student at the Orthodontic Department, University of Damascus DentalKinda sultan, DDS,MSc,PhD, Study chair, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010616
- Sponsor's protocol ID
- UDDS-Ortho-07-2021
- Status last verified
- Nov 2022
- First submitted
- 11 Aug 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28686090Hadadpour 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.
PubMed 31784021Izhar 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.
PubMed 32110468Noroozi 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.
PubMed 12490870Buschang 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.
PubMed 25372019Kusaibati 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.
PubMed 37777351
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05010616
- Acronym / sponsor ID
- UDDS-Ortho-07-2021
- Conditions
- Crowding, Tooth
- Keywords
- Crowding, Simulation, Prediction, Expectation, Satisfaction, Three-dimensional set up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional digital simulation with fixed appliance | Experimental | Device: Fixed orthodontic appliancesThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Bimaxillary dentoalveolar severe protrusion.
- Need for extraction.
- Previous orthodontic treatment.
- Subject with psychological abnormalities.
- congenitally missing or extracted teeth (except for the third molars).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed orthodontic appliancesVisual 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. | Device | Three-dimensional digital simulation with fixed appliance |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 28686090Grunheid 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.
- Background: PubMed 31784021Hadadpour 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.
- Background: PubMed 32110468Izhar 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.
- Background: PubMed 12490870Noroozi 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.
- Background: PubMed 25372019Buschang 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.
- Derived from this study: PubMed 37777351Kusaibati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd Alrahman Qusaibati, DDS principal investigator
MSc student at the Orthodontic Department, University of Damascus Dental
Kinda sultan, DDS,MSc,PhD study chair
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed orthodontic appliances in people with Crowding, Tooth, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010616, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.