Malocclusion, Angle Class INCT06253286

Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time

A study testing clear aligner treatment for orthodontics patients in people with Malocclusion, Angle Class I, run by Future University in Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria. Treatment planning will be done on Maestro® software. An impression will be taken and scanned by an extra-oral scanner. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Malocclusion, Angle Class I
What is being tested?: clear aligner treatment for orthodontics patients
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteEgypt
Study dates: 1 Nov 2020to 1 Dec 2023
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Permeant dentition
Mild to moderate crowding and spacing in maxilla and mandible according to Little's Irregularity Index
Non-extraction cases

Who cannot join

Severe crowding and spacing
Systematic diseases
Compromised periodontal health
Craniofacial syndromes

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Future University in Egypt
Cairo, New Caro, 11865

Other trials in Egypt

About this study

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria.

Treatment planning will be done on Maestro® software. An impression will be taken and scanned by an extra-oral scanner. The models will be 3D printed and aligner trays will be fabricated to be delivered on biweekly basis to be worn 16 hours per day for one group and 22 hours for the other group. Superimposition of the achieved clinical model over the predicted model will be done. Linear and angular measurements will be calculated for each tooth.

Read the detailed description

Clear removable retainers could be related to clear aligners. Wearing time of retainers has been suggested that it could be changed from full time to part-time during the night only. A similar approach could be done to determine the effect of wearing time of clear aligners on treatment outcome. The standard duration per day for wearing the appliance is 22 hours. However, is part-time wearing (16 hours) would have the same effect? Therefore, a randomized clinical trial is needed to compare the effect of partial wearing of the aligner versus full time. Moreover, studying the predictability and accuracy of treatment using Maestro software.

Conditions: Malocclusion, Angle Class I
Being tested: clear aligner treatment for orthodontics patients
Medical subject headings: Malocclusion, Angle Class I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clear aligner treatment for orthodontics patientsDevice
patient are instructed to wear aligners

Study groups in NCT06253286
Study group	Role	What they receive
part-time wear	Active comparator	Patients will be instructed to wear the aligner for 16 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software Receives: Device: clear aligner treatment for orthodontics patients
Full-time wear	Active comparator	Patients will be instructed to wear the aligner for 22 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software Receives: Device: clear aligner treatment for orthodontics patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Linear Movement Discrepancies Between Digital Software Models and Clinical Models
Translation movements (mm) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups
Measured: an average of 1 year
Angular Movement Discrepancies Between Digital Software Models and Clinical Models
Translation movements (Degrees) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups
Measured: an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20201 Dec 2023

First posted12 Feb 2024
Study start1 Nov 2020
Primary completion1 May 2022
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Malocclusion, Angle Class IStudies 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: Randomised
Intervention model: Parallel groups
Model description: A randomized controlled clinical trial of 2 parallel groups with an allocation ratio of 1:1
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06253286
Sponsor's protocol ID: FUE.REC (24)/11-2020
Status last verified: Feb 2024
First submitted: 27 Jun 2021
Last updated: 12 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The trial results will be available to the participants, health care professionals and the public by publication of the study in high quality national and international journals. The principal investigator will present a copy of the thesis at the Faculty of Oral and Dental Medicine, Future University in Egypt library and will distribute additional copies among the main universities in Egypt.

Publications

Nahoum HI. Forces and moments generated by removable thermoplastic aligners. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):545-6. doi: 10.1016/j.ajodo.2014.08.006. Epub 2014 Oct 28. No abstract available.
PubMed 25439196
Djeu G, Shelton C, Maganzini A. Outcome assessment of Invisalign and traditional orthodontic treatment compared with the American Board of Orthodontics objective grading system. Am J Orthod Dentofacial Orthop. 2005 Sep;128(3):292-8; discussion 298. doi: 10.1016/j.ajodo.2005.06.002.
PubMed 16168325
Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
PubMed 30264270
Melsen B. Northcroft lecture: how has the spectrum of orthodontics changed over the past decades? J Orthod. 2011 Jun;38(2):134-43; quiz 145. doi: 10.1179/14653121141362.
PubMed 21677105
Pratt MC, Kluemper GT, Lindstrom AF. Patient compliance with orthodontic retainers in the postretention phase. Am J Orthod Dentofacial Orthop. 2011 Aug;140(2):196-201. doi: 10.1016/j.ajodo.2010.02.035.
PubMed 21803257
Kacer KA, Valiathan M, Narendran S, Hans MG. Retainer wear and compliance in the first 2 years after active orthodontic treatment. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):592-8. doi: 10.1016/j.ajodo.2008.12.027.
PubMed 21055599
Jacox LA, Mihas P, Cho C, Lin FC, Ko CC. Understanding technology adoption by orthodontists: A qualitative study. Am J Orthod Dentofacial Orthop. 2019 Mar;155(3):432-442. doi: 10.1016/j.ajodo.2018.08.018.
PubMed 30826046
Alford TJ, Roberts WE, Hartsfield JK Jr, Eckert GJ, Snyder RJ. Clinical outcomes for patients finished with the SureSmile method compared with conventional fixed orthodontic therapy. Angle Orthod. 2011 May;81(3):383-8. doi: 10.2319/071810-413.1. Epub 2011 Jan 24.
PubMed 21261488
Brown MW, Koroluk L, Ko CC, Zhang K, Chen M, Nguyen T. Effectiveness and efficiency of a CAD/CAM orthodontic bracket system. Am J Orthod Dentofacial Orthop. 2015 Dec;148(6):1067-74. doi: 10.1016/j.ajodo.2015.07.029.
PubMed 26672713
Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
PubMed 19121497
Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.
PubMed 26629473
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.
PubMed 25372019
Weir T. Clear aligners in orthodontic treatment. Aust Dent J. 2017 Mar;62 Suppl 1:58-62. doi: 10.1111/adj.12480.
PubMed 28297094
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 28686090
Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20.
PubMed 25412265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
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Malocclusion, Angle Class I, Malocclusion, Angle Class II
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Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
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Clinical Performance of Direct-Printed Versus Thermoformed Aligners
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All Malocclusion, Angle Class I trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time
ClinicalTrials.gov ID: NCT06253286
Acronym / sponsor ID: FUE.REC (24)/11-2020
Conditions: Malocclusion, Angle Class I
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Future University in EgyptUniversity, hospital or other
Study start: 1 Nov 2020 (actual)
Primary completion: 1 May 2022 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 12 Feb 2024 (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.

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: A randomized controlled clinical trial of 2 parallel groups with an allocation ratio of 1:1

Arm	Type	Receives
part-time wear	Active comparator	Device: clear aligner treatment for orthodontics patientsPatients will be instructed to wear the aligner for 16 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software
Full-time wear	Active comparator	Device: clear aligner treatment for orthodontics patientsPatients will be instructed to wear the aligner for 22 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Permeant dentition
Mild to moderate crowding and spacing in maxilla and mandible according to Little's Irregularity Index
Non-extraction cases

Key exclusion criteria (4 listed)

Severe crowding and spacing
Systematic diseases
Compromised periodontal health
Craniofacial syndromes

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
clear aligner treatment for orthodontics patientspatient are instructed to wear aligners	Device	Full-time wear, part-time wear

Primary outcome

Linear Movement Discrepancies Between Digital Software Models and Clinical Models
Time frame: an average of 1 year
Translation movements (mm) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups
Angular Movement Discrepancies Between Digital Software Models and Clinical Models
Time frame: an average of 1 year
Translation movements (Degrees) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups

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 12 Feb 2024.
Background: PubMed 25439196Nahoum HI. Forces and moments generated by removable thermoplastic aligners. Am J Orthod Dentofacial Orthop. 2014 Nov;146(5):545-6. doi: 10.1016/j.ajodo.2014.08.006. Epub 2014 Oct 28. No abstract available.
Background: PubMed 16168325Djeu G, Shelton C, Maganzini A. Outcome assessment of Invisalign and traditional orthodontic treatment compared with the American Board of Orthodontics objective grading system. Am J Orthod Dentofacial Orthop. 2005 Sep;128(3):292-8; discussion 298. doi: 10.1016/j.ajodo.2005.06.002.
Background: PubMed 30264270Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z.
Background: PubMed 21677105Melsen B. Northcroft lecture: how has the spectrum of orthodontics changed over the past decades? J Orthod. 2011 Jun;38(2):134-43; quiz 145. doi: 10.1179/14653121141362.
Background: PubMed 21803257Pratt MC, Kluemper GT, Lindstrom AF. Patient compliance with orthodontic retainers in the postretention phase. Am J Orthod Dentofacial Orthop. 2011 Aug;140(2):196-201. doi: 10.1016/j.ajodo.2010.02.035.
Background: PubMed 21055599Kacer KA, Valiathan M, Narendran S, Hans MG. Retainer wear and compliance in the first 2 years after active orthodontic treatment. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):592-8. doi: 10.1016/j.ajodo.2008.12.027.
Background: PubMed 30826046Jacox LA, Mihas P, Cho C, Lin FC, Ko CC. Understanding technology adoption by orthodontists: A qualitative study. Am J Orthod Dentofacial Orthop. 2019 Mar;155(3):432-442. doi: 10.1016/j.ajodo.2018.08.018.
Background: PubMed 21261488Alford TJ, Roberts WE, Hartsfield JK Jr, Eckert GJ, Snyder RJ. Clinical outcomes for patients finished with the SureSmile method compared with conventional fixed orthodontic therapy. Angle Orthod. 2011 May;81(3):383-8. doi: 10.2319/071810-413.1. Epub 2011 Jan 24.
Background: PubMed 26672713Brown MW, Koroluk L, Ko CC, Zhang K, Chen M, Nguyen T. Effectiveness and efficiency of a CAD/CAM orthodontic bracket system. Am J Orthod Dentofacial Orthop. 2015 Dec;148(6):1067-74. doi: 10.1016/j.ajodo.2015.07.029.
Background: PubMed 19121497Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.
Background: PubMed 26629473Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.
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.
Individual participant dataSharing planned: Yes. The trial results will be available to the participants, health care professionals and the public by publication of the study in high quality national and international journals. The principal investigator will present a copy of the thesis at the Faculty of Oral and Dental Medicine, Future University in Egypt library and will distribute additional copies among the main universities in Egypt.

Related trials for Malocclusion, Angle Class I

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Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
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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.

Hala Mounir, Prof study chair

Future University in Egypt

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing clear aligner treatment for orthodontics patients in people with Malocclusion, Angle Class I, run by Future University in Egypt at 1 site in Egypt.

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 3 inclusion and 4 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 12 Feb 2024. 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 Egypt. 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?

Linear Movement Discrepancies Between Digital Software Models and Clinical Models (time frame: an average of 1 year). The study lists 2 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 NCT06253286, which also lists 22 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 12 Feb 2024.