Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

Study Overview
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Brief Summary
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The primary objective of this research is to compare the rate of canine retraction following the osteoperforation and piezocorticision procedures in cases of first premolar extractions. The secondary objectives are to compare the second order movement of the canine (tipping), the amount of root resorption associated with the procedures, the inflammation process by measuring the inflammatory markers in the gingival crevicular fluid, the loss of posterior anchorage by measures on the cone beam computed tomography (CBCT) 3-dimensional radiograph and on the casts and to evaluate the pain level and the impact on quality of life following each procedure using the questionnaire of the visual analogue scale (VAS) of pain.

Official Title
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Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.

Conditions
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Piezocorticision, Osteoperforation, Canine Retraction, Orthodontic Treatment

Intervention / Treatment
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* Procedure: Piezocorticision
* Procedure: Osteoperforation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dental and/or skeletal Cl I and II requiring maxillary first premolar extraction. Young adults 16 years and older. Good overall health. Complete adult dentition. Cooperative. Acceptable hygiene. Absence of any periodontal disease (gingivitis, periodontitis). Exclusion Criteria: Non-cooperative, fearful patients or patients with intellectual disability. Patients requiring the regular use of nonsteroidal anti-inflammatory drugs (NSAID). Use of antibiotics in the last 6 months. Previous or current use of bisphosphonates, corticosteroids or immunosuppressive drugs. Smokers. Patients suffering from uncontrolled systemic diseases (ex. diabetes type I and II). Presence of oral or maxillofacial malformations (ex. cleft palate) or dental pathologies (ex. ankylosis, abscess).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A split mouth design will be used where the experimental subjects will receive one procedure on one side of the upper dental arch and another procedure on the other side.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezocorticision and osteoperforation group<br>All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side. | Procedure: Piezocorticision<br>* The piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome.<br>Procedure: Osteoperforation<br>* The osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool.<br>|
| No Intervention: Control<br>The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of canine retraction | The speed at which the canine is moved in the space of the extracted premolar. | From the time of force application until the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks. Measures will be taken at two week intervals. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tipping | The angulation of the long axis of the canine at the end of the retraction. | The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks | 
| Amount of root resorption | The total reduction in volume of the root of the canine caused by the canine retraction measured on the cone beam computed tomography. | The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks | 
| Amount of posterior loss of anchorage | Measure of the amount of anterior movement of the posterior teeth during the retraction of the canine. | The measure is taken when the distal of the canine touches the mesial of the second premolar. We estimate the time frame to be up to 24 weeks | 
| Concentration of IL-1 in the gingival fluid sample | Measure of the concentration of IL-I using the Luminex technique. | Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks. | 
| Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample | Measure of the concentration of RANKL using the Luminex technique. | Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks. | 
| Concentration of osteoprotegerin (OPG) in the gingival fluid sample | Measure of the concentration of OPG using the Luminex technique. | Measures are taken immediately before the periodontal procedures, then at 1,3,8 weeks and when the distal of the canine touches the mesial surface of the second premolar which can take up to 24 weeks. | 
| Level of pain | Measure of the level of pain using a visual analogue scale of pain questionnaire ranging from 0-10. | Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures |