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
Verified date | March 2020 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Orthodontic Department, University of Hama Dental School | Hamah |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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
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 |
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