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CompletedNCT06253286Updated Feb 12, 2024

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

An interventional study of clear aligner treatment for orthodontics patients in Malocclusion, Angle Class I, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Malocclusion, Angle Class I
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Severe crowding and spacing
  2. Systematic diseases
  3. Compromised periodontal health
  4. Craniofacial syndromes
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    part-time wear

    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

    Device: clear aligner treatment for orthodontics patients

  • Active comparator
    Full-time wear

    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

    Device: clear aligner treatment for orthodontics patients

Interventions

  • Deviceclear aligner treatment for orthodontics patients

    patient are instructed to wear aligners

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: an average of 1 year

  2. 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

    Time frame: an average of 1 year

06

Study locations

1 site
  • Future University in Egypt
    Cairo, New Caro 11865, Egypt
07

References and documents

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 ↗
  • Simon M, Keilig L, Schwarze J, Jung BA, Bourauel C. Treatment outcome and efficacy of an aligner technique--regarding incisor torque, premolar derotation and molar distalization. BMC Oral Health. 2014 Jun 11;14:68. doi: 10.1186/1472-6831-14-68. PubMed 24923279 ↗
  • Charalampakis O, Iliadi A, Ueno H, Oliver DR, Kim KB. Accuracy of clear aligners: A retrospective study of patients who needed refinement. Am J Orthod Dentofacial Orthop. 2018 Jul;154(1):47-54. doi: 10.1016/j.ajodo.2017.11.028. PubMed 29957318 ↗
  • 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. PubMed 32110468 ↗
  • Lombardo L, Arreghini A, Ramina F, Huanca Ghislanzoni LT, Siciliani G. Predictability of orthodontic movement with orthodontic aligners: a retrospective study. Prog Orthod. 2017 Nov 13;18(1):35. doi: 10.1186/s40510-017-0190-0. PubMed 29130127 ↗
  • Chisari JR, McGorray SP, Nair M, Wheeler TT. Variables affecting orthodontic tooth movement with clear aligners. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S82-91. doi: 10.1016/j.ajodo.2013.10.022. PubMed 24680028 ↗
  • Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14. PubMed 19828592 ↗
  • Gill DS, Naini FB, Jones A, Tredwin CJ. Part-time versus full-time retainer wear following fixed appliance therapy: a randomized prospective controlled trial. World J Orthod. 2007 Fall;8(3):300-6. PubMed 17902334 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT06253286
Lead sponsor
Future University in Egypt
Responsible party
Mohamed Adel Zein (Principle Investigator, Future University in Egypt) — Principal investigator
First posted
Feb 12, 2024
Start date
Nov 1, 2020
Primary completion
May 1, 2022
Completion
Dec 1, 2023
Last update
Feb 12, 2024

Study contacts

Hala Mounir, Prof
study chair · Future University in Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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