Evaluation of the Effects of Osteoperforation and Piezocorticision on Canine Retraction: Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Université de Montréal
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Rate of canine retraction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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).
Arms & Interventions
Piezocorticision and osteoperforation group
All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side.
Intervention: Piezocorticision (Procedure)
Control
The participants in this arm will receive no treatment, but will have the same monitoring as the experimental group.
Piezocorticision and osteoperforation group
All participants in this arm will receive the piezocorticision and osteoperforation procedures on the upper jaw on the left and the right side.
Intervention: Osteoperforation (Procedure)
Outcomes
Primary Outcomes
Rate of canine retraction
Time Frame: 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 Outcomes
- 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.)
- Level of pain(Daily, for 7 days following extraction of premolars and piezocorticision and osteoperforation procedures)
- 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.)
- 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)
- 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)
- 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)
- 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.)
Investigators
Le George Dinh-Khang
Principal investigator
Université de Montréal