Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction

Class II Division 1 Malocclusion Clinical Trial

Official title:

Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316403
• Other study ID #: UDDS-Ortho-01-2020
• Status: Completed
• Phase: N/A
• Start date: February 15, 2015
• Est. completion date: September 15, 2017

Study information

• Verified date: March 2020
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Division 1 Malocclusion
• Malocclusion
• Maxillary Prognathism
• Prognathism
• Protrusion, Incisor

Intervention

Procedure:
• Er:YAG laser
This application was made before the onset of canine retraction in one side of the mouth

Locations

Country	Name	City	State
Syrian Arab Republic	Orthodontic Department, University of Hama Dental School	Hamah

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. Erratum in: Angle Orthod. 2018 Jan;88(1):125. — View 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. — View Citation

Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the canine retraction rate	The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.	10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application
Secondary	Change in the levels of pain and discomfort	A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions: Question 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side?; The possible answers were: 1. No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was.; Question 5: Which one of the following has caused more discomfort to you?; 1. Extraction of premolars 2. Laser application 3.Both	at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application