Clinical trial NCT03308851: Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction
Official title: Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Piezocorticision
Osteoperforation
Canine Retraction
Orthodontic Treatment
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2017-10-13
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of canine retraction
timeFrame: 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 outcomes:
measure: Amount of tipping
timeFrame: 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: Amount of root resorption
timeFrame: 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: Amount of posterior loss of anchorage
timeFrame: 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: Concentration of IL-1 in the gingival fluid sample
timeFrame: 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: Concentration of receptor activator of nuclear factor kappa-B ligand (RANKL) in the gingival fluid sample
timeFrame: 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: Concentration of osteoprotegerin (OPG) in the gingival fluid sample
timeFrame: 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: Level of pain
timeFrame: Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique d'orthodontie de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Clarice Nishio, D.M.D, MSc, PhD
role: STUDY_DIRECTOR
References: