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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03308851
Other study ID # Piezo and Osteoperforation
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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