Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

Not Applicable

Terminated

• Conditions: Canine Retraction; Piezocorticision; Osteoperforation; Orthodontic Treatment
• Interventions: Procedure: Piezocorticision; Procedure: Osteoperforation

• Registration Number: NCT03308851
• Lead Sponsor: Université de Montréal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-13
• Study Start: 2018-01-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Piezocorticision and osteoperforation group	Osteoperforation	All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side.
Piezocorticision and osteoperforation group	Piezocorticision	All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side.

Primary Outcome Measures

Name	Time	Method
Rate of canine retraction	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.	The speed at which the canine is moved in the space of the extracted premolar.

Secondary Outcome Measures

Name	Time	Method
Level of pain	Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures	Measure of the level of pain using a visual analogue scale of pain questionnaire ranging from 0-10.
Concentration of IL-1 in the gingival fluid sample	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.	Measure of the concentration of IL-I using the Luminex technique.
Amount of tipping	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	The angulation of the long axis of the canine at the end of the retraction.
Amount of root resorption	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	The total reduction in volume of the root of the canine caused by the canine retraction measured on the cone beam computed tomography.
Amount of posterior loss of anchorage	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	Measure of the amount of anterior movement of the posterior teeth during the retraction of the canine.
Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample	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.	Measure of the concentration of RANKL using the Luminex technique.
Concentration of osteoprotegerin (OPG) in the gingival fluid sample	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.	Measure of the concentration of OPG using the Luminex technique.

Trial Locations

Locations (1)

Clinique d'orthodontie de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada