Class II Malocclusion Clinical Trial
Official title:
Comparison Between the Effect of Piezocision and Low-level Laser Therapy on Patient-centered Outcomes in Patients Undergoing Upper Canine Retraction
Verified date | October 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
54 patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time. There are three groups: The first group (control group): the canine retraction in this group will be performed in conventional method. The second group (Experimental group): the canine retraction in this group will be performed in association with piezocision. The third group (Experimental group): the canine retraction in this group will be performed in association with low-level laser therapy.
Status | Completed |
Enrollment | 58 |
Est. completion date | November 30, 2022 |
Est. primary completion date | July 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 28 Years |
Eligibility | Inclusion Criteria: 1. Adult healthy patients, Male and female, Age range: 17-28 years. 2. Class II Division 1 malocclusion : - Mild/moderate skeletal Class II (sagittal discrepancy angle =7) - Overjet =10 - Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) - Mild to moderate crowding = 4 3. Permanent occlusion. 4. Existence of all the upper teeth (except third molars). 5. Good oral and periodontal health: - Probing depth < 4 mm - No radiographic evidence of bone loss. - Gingival index = 1 - Plaque index = 1 Exclusion Criteria: 1. Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …) 2. Presence of primary teeth in the maxillary arch 3. Missing permanent maxillary teeth (except third molars). 4. Poor oral hygiene or Current periodontal disease: - Probing depth = 4 mm - radiographic evidence of bone loss - Gingival index > 1 - Plaque index > 1 5. Patient had previous orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19. — View Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181. — View Citation
Farid KA, Eid AA, Kaddah MA, Elsharaby FA. The effect of combined corticotomy and low level laser therapy on the rate of orthodontic tooth movement: split mouth randomized clinical trial. Laser Ther. 2019 Dec 31;28(4):275-283. doi: 10.5978/islsm.19-OR-19. — View Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9. — View Citation
Keser E, Naini FB. Accelerated orthodontic tooth movement: surgical techniques and the regional acceleratory phenomenon. Maxillofac Plast Reconstr Surg. 2022 Jan 5;44(1):1. doi: 10.1186/s40902-021-00331-5. — View Citation
Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the levels of pain | Assessment will be performed using questionnaires via Visual Analog scale. | T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction. | |
Primary | Change in the levels of discomfort | Assessment will be performed using questionnaires via Visual Analog scale. | T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction. | |
Primary | Change in the levels of swelling | Assessment will be performed using questionnaires via Visual Analog scale. | T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction. | |
Primary | Levels of Eating difficulty | Assessment will be performed using questionnaires via Visual Analog scale. | T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction. | |
Primary | Change in the levels of satisfaction | Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No. | T5: 28 days following the commencement of the retraction. |
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