Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .
NCT ID: NCT06526871
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-10-25
2024-07-03
Brief Summary
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Detailed Description
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Intervention:
The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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control group
ten patients treated with removable clear aligner
clear aligner therapy
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
ten patients treated with removable clear aligner with application of Low-Level-Laser
Low-Level Laser acceleration
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 .
clear aligner therapy
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.
Interventions
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Low-Level Laser acceleration
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 .
clear aligner therapy
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients from 16 to 23 years old .
3. Patients with mild to moderate anterior lower crowding.
4. Full complement of teeth (except for wisdom teeth).
5. Class I Angle malocclusion .
Exclusion Criteria
2. Class II or III Malocclusion (dental or skeletal ) .
3. Any systemic diseases that may interfere with assigned treatment plan .
4. Periodontal affection especially at lower anterior teeth .
16 Years
23 Years
FEMALE
No
Sponsors
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Huda Abdelhakim
OTHER_GOV
Responsible Party
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Huda Abdelhakim
Doctor
Principal Investigators
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Samir A Ibrahim, professor
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University
Locations
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AL-Azhar university
Cairo, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
13. Cokakoglu S. , Aydoğan F. Aydın B. low level laser therapy in orthodontics . Meandros Med Dent J.2018;19:99-105 .
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.
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 .
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ORTHO-109-2-K
Identifier Type: -
Identifier Source: org_study_id
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