Malocclusion Clinical Trial
Official title:
Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
Verified date | July 2017 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The efficacy of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy. The time required to achieve complete alignment of crowded mandibular anterior teeth (from canine to canine) will be compared between the two groups.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 27 Years |
Eligibility |
Inclusion Criteria: 1. Adult healthy patients , Male and female, Age range: 15-27 years. 2. Severe crowding = 7 (Little's irregularity index) 3. Permanent occlusion. 4. Exist all the Mandibular 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, NSAIDs, …) 2. Patients have anti indication for oral surgery ( medical - social - psycho) 3. Presence of primary teeth in the mandibular arch 4. Missing permanent mandibular teeth (except third molars). 5. Poor oral hygiene or Current periodontal disease: - Probing depth = 4 mm - radiographic evidence of bone loss - Gingival index > 1 - Plaque index > 1 6. Patient had previous orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014. — View Citation
Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French. — View Citation
Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of tooth alignment | This outcome will be measured in 'days'. | This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation | |
Primary | Change in Tooth Alignment at one month | This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | Little Index of Irregularity will be measured at 30 days after the onset of treatment. | |
Primary | Change in Tooth Alignment at two months | This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | Little Index of Irregularity will be measured at 60 days after the onset of treatment. | |
Primary | Change in Tooth Alignment at last assessment time | This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment. |
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