Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment

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 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.

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 for their effectiveness so far has been limited to case series and a few clinical trials, generally with small groups. This study aims to provide some evidence about the efficacy of piezosurgery in a flapless technique to align crowded lower anterior teeth using a parallel-group randomized controlled trial study design.

Official Title
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Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial

Conditions
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Surgical Incision, Malocclusion

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: 15-27 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: 15 Years
Maximum Age: 27 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 will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding. | Procedure: Piezosurgery<br>* The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.<br>* Other names: Piezocision;|
| No Intervention: Ordinary Alignment<br>Treatment will be provided to the patients without any surgical interventions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticotomy, piezocision, piezosurgery, acceleration of tooth movement, crowded anterior teeth