Clinical trial NCT04316403: Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction
Official title: Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Division 1 Malocclusion
Maxillary Prognathism
Protrusion, Incisor
Keywords: Tooth movement
Acceleration of tooth movement
Er:YAG laser-assisted corticotomy
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.

Detailed description: Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months in mild and severe cases. Prolonged treatment time can cause many adverse effects such as pain, discomfort, external root resorption, white spots and dental caries. Decreasing the treatment time for tooth movement has been the focus of both the clinicians and the patients. For the last few decades, investigators have recommended many treatment approaches intending to reduce overall treatment time such as low friction and self-ligating bracket systems, low-level laser irradiation, electrical currents, pharmacological approaches, local platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction and selective alveolar decortication or corticotomy

Eligibility criteria: Inclusion Criteria:

* Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
* Permanent dentition with an age range from 16 to 24 years.
* Healthy with no systemic conditions.
* Adequate oral hygiene and healthy periodontal tissues
* no previous orthodontic treatment
* Absence of canine endodontic treatment.

Exclusion Criteria:

* Bimaxillary dentoalveolar severe protrusion.
* Previous orthodontic treatment.
* Subject with psychological abnormalities.
* Subject with systemic diseases.

Primary outcomes:
measure: Change in the canine retraction rate
timeFrame: 10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application
Secondary outcomes:
measure: Change in the levels of pain and discomfort
timeFrame: at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application
Other outcomes:
Locations:
city: Hamah
country: Syrian Arab Republic
facility: Orthodontic Department, University of Hama Dental School
Study officials:
affiliation: PhD student, Orthodontics Department, University of Damascus Dental School
name: Samer T Jaber, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Hama, Hama, Syria
name: Rabab Al-sabbagh, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.
citation: Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.
citation: Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.
citation: Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
citation: 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.
citation: Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.
citation: Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.