Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .

NCT06526871 | Completed

• 1 other identifier: ORTHO-109-2-K
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners

Conditions

Tooth Movement

Keywords

Aligner; Crowding; Laser

Outcome Measures

Primary Outcomes (1)

• • Little irregularity index

  The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.

  through study completion, an average of 6 months

Secondary Outcomes (7)

• • Treatment time

  through study completion, an average of 6 months

• • Number of aligners

  through study completion, an average of 6 months

• • Patient comfort and satisfaction

  through study completion, an average of 6 months

• • Refinement rate

  through study completion, an average of 6 months

• • Digital cast accuracy

  through study completion, an average of 6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

ten patients treated with removable clear aligner

Procedure: clear aligner therapy

Experimental group

EXPERIMENTAL

ten patients treated with removable clear aligner with application of Low-Level-Laser

Procedure: Low-Level Laser acceleration; Procedure: clear aligner therapy

Interventions

Low-Level Laser acceleration PROCEDURE

This intervention involves the application of Low-Level Laser Therapy (LLLT) using the Epic X device for patients undergoing orthodontic treatment. The protocol is designed to assess the effects of LLLT on pain reduction and treatment efficacy during the initial leveling and alignment phase of orthodontic therapy using clear aligners .

Experimental group

clear aligner therapy PROCEDURE

Clear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces.

Experimental group; control group

Eligibility Criteria

• Age: 16 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A well-behaved, compliant, and motivated patient.
• Patients from 16 to 23 years old .
• Patients with mild to moderate anterior lower crowding.
• Full complement of teeth (except for wisdom teeth).
• Class I Angle malocclusion .

You may not qualify if:

• Patients with missed anterior teeth .
• Class II or III Malocclusion (dental or skeletal ) .
• Any systemic diseases that may interfere with assigned treatment plan .
• Periodontal affection especially at lower anterior teeth .

Sponsors & Collaborators

• Huda Abdelhakim: lead

Study Sites (1)

AL-Azhar university

Cairo, Egypt

Location

Related Publications (16)

• Das PJ, Dkhar W, Pradhan A. An Evaluation of Dental Crowding in Relation to the Mesiodistal Crown Widths and Arch Dimensions in Southern Indian Population. J Clin Diagn Res. 2017 Sep;11(9):TC10-TC13. doi: 10.7860/JCDR/2017/29642.10554. Epub 2017 Sep 1.

  PMID: 29207804 BACKGROUND

• Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.

  PMID: 35663697 BACKGROUND

• Knosel M, Nuser C, Jung K, Helms HJ, Engelke W, Sandoval P. Interaction between deglutition, tongue posture, and malocclusion: A comparison of intraoral compartment formation in subjects with neutral occlusion or different types of malocclusion. Angle Orthod. 2016 Sep;86(5):697-705. doi: 10.2319/101615-699.1. Epub 2016 Feb 19.

  PMID: 26894981 BACKGROUND

• Tamer I, Oztas E, Marsan G. Orthodontic Treatment with Clear Aligners and The Scientific Reality Behind Their Marketing: A Literature Review. Turk J Orthod. 2019 Dec 1;32(4):241-246. doi: 10.5152/TurkJOrthod.2019.18083. eCollection 2019 Dec.

  PMID: 32110470 BACKGROUND

• Hennessy J, Garvey T, Al-Awadhi EA. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners. Angle Orthod. 2016 Sep;86(5):706-12. doi: 10.2319/101415-686.1.

  PMID: 27571371 BACKGROUND

• Baghizadeh Fini M, Olyaee P, Homayouni A. The Effect of Low-Level Laser Therapy on the Acceleration of Orthodontic Tooth Movement. J Lasers Med Sci. 2020 Spring;11(2):204-211. doi: 10.34172/jlms.2020.34. Epub 2020 Mar 15.

  PMID: 32273964 BACKGROUND

• Sharma R, Drummond R, Wiltshire W, Schroth R, Lekic M, Bertone M, Tate R. Quality of life in an adolescent orthodontic population. Angle Orthod. 2021 Nov 1;91(6):718-724. doi: 10.2319/062820-592.1.

  PMID: 34260709 BACKGROUND

• Ghaffar YKA, El Sharaby FA, Negm IM. Effect of low-level laser therapy on the time needed for leveling and alignment of mandibular anterior crowding. Angle Orthod. 2022 Jul 1;92(4):478-486. doi: 10.2319/102721-795.1.

  PMID: 35344012 BACKGROUND

• Soares Bonato RC, Abel Mapengo MA, de Azevedo-Silva LJ, Janson G, de Carvalho Sales-Peres SH. Tooth movement, orofacial pain, and leptin, interleukin-1beta, and tumor necrosis factor-alpha levels in obese adolescents. Angle Orthod. 2022 Jan 1;92(1):95-100. doi: 10.2319/011321-44.1.

  PMID: 34338736 BACKGROUND

• Bakdach WMM, Hadad R. Effectiveness of low-level laser therapy in accelerating the orthodontic tooth movement: A systematic review and meta-analysis. Dent Med Probl. 2020 Jan-Mar;57(1):73-94. doi: 10.17219/dmp/112446.

  PMID: 32314880 BACKGROUND

• Cossetin E, Janson G, de Carvalho MG, de Carvalho RA, Henriques JF, Garib D. Influence of low-level laser on bone remodeling during induced tooth movement in rats. Angle Orthod. 2013 Nov;83(6):1015-21. doi: 10.2319/100812-789.1. Epub 2013 May 14.

  PMID: 23672280 BACKGROUND

• Guram G, Reddy RK, Dharamsi AM, Syed Ismail PM, Mishra S, Prakashkumar MD. Evaluation of Low-Level Laser Therapy on Orthodontic Tooth Movement: A Randomized Control Study. Contemp Clin Dent. 2018 Jan-Mar;9(1):105-109. doi: 10.4103/ccd.ccd_864_17.

  PMID: 29599594 BACKGROUND

• 13. Cokakoglu S. , Aydoğan F. Aydın B. low level laser therapy in orthodontics . Meandros Med Dent J.2018;19:99-105 .

  BACKGROUND

• AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.

  PMID: 27869476 BACKGROUND

• 15. Ponciano F. A. S. , Gutiérrez-Rojo M. F. , Gutiérrez-Rojo J. F. .Crowding severity associated with dental mass . Revista Mexicana de Ortodoncia .2016;4:165-8 .

  BACKGROUND

• Masucci C, Oueiss A, Maniere-Ezvan A, Orthlieb JD, Casazza E. [What is a malocclusion?]. Orthod Fr. 2020 Jun 1;91(1-2):57-67. doi: 10.1684/orthodfr.2020.11. French.

  PMID: 33146134 BACKGROUND

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Samir A Ibrahim, professor

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: October 25, 2022
• Primary Completion: June 2, 2024
• Study Completion: July 3, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)