Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth

Study Overview
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Brief Summary
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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 levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

Detailed Description
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According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time. Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

Official Title
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Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial

Conditions
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Malocclusion, Crowded Teeth, Surgical Incision

Intervention / Treatment
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* Procedure: Piezosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy patients , Male and female, Age range: 16-26 years. Severe crowding ≤ 7 (Little's irregularity index) Permanent occlusion. Exist all the Mandibular teeth (except third molars). Good oral and periodontal health: Probing depth<4 mm No radiographic evidence of bone loss . Gingival index≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical problems that affect tooth movement (corticosteroid, NSAIDs, …) Patients have anti indication for oral surgery ( medical - social - psycho) Presence of primary teeth in the mandibular arch Missing permanent mandibular teeth (except third molars). Poor oral hygiene or Current periodontal disease: Probing depth ≥ 4 mm radiographic evidence of bone loss Gingival index > 1 Plaque index > 1 Patient had previous orthodontic treatment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezosurgery<br>Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment | Procedure: Piezosurgery<br>* The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.<br>* Other names: Piezocision;|
| No Intervention: Traditional method<br>No intervention is going to be applied to the patients in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Pain and Discomfort at one day | Pain and discomfort will be measured on visual analog scale | at 24 hours following the engagement of first initial arch wire in the brackets | 
| Levels of Pain and Discomfort at seven days | Pain and discomfort will be measured on visual analog scale | at seven days following the onset of orthodontic treatment | 
| Levels of Pain and Discomfort at 14 days | Pain and discomfort will be measured on visual analog scale | at 14 days following the onset of orthodontic treatment | 
| Levels of Pain and Discomfort at 28 days | Pain and discomfort will be measured on visual analog scale | at 28 days following the onset of orthodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort