Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction

Orthodontic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03308851
• Other study ID #: Piezo and Osteoperforation
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Canine Retraction
• Orthodontic Treatment
• Osteoperforation
• Piezocorticision

Intervention

Procedure:
• Piezocorticision
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.
• Osteoperforation
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.

Locations

Country	Name	City	State
Canada	Clinique d'orthodontie de l'Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	University of Michigan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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