|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02359760 |
|
Date of registration:
|
04/02/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study
|
|
Scientific title:
|
Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
14 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02359760 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Julien Strippoli, DMD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Montreal, orthodontic department |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- normal or low skeletal problem;
- dental relationchip without extraction;
- healthy;
- complete adult teeth;
- very cooperative;
- no plaque;
- no active periodontal disease and no bone loss visible radiographically;
- patient wishing a shorter orthodontic treatment.
Exclusion Criteria:
- patient regularly taking analgesic and antidepressants.
- patients with alcool abuse problems.
- patient smoking more than 10 cigarettes per day.
- pregnant patient.
- allergy to non-steroidal anti-inflammatory drugs.
- local or systemic Immunodeficiencies.
- uncontrolled systemic disease (For exaemple diabetes, cardiovascular disease).
- coagulation problems or taking anti-coagulants.
- presence of oral infections and periodontal disease uncontrolled active.
- taking intravenous bisphosphonates or taking oral bisphosphonates for more than 4
years.
- taking a long-term corticosteroids.
- antibiotic necessary before any surgery and taking antibiotics within 6 months before
surgery
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Malocclusion
|
|
Intervention(s)
|
|
Procedure: Piezocision
|
|
Primary Outcome(s)
|
|
Determine the duration of orthodontic treatment associated with Piezocision
[Time Frame: 18 months]
|
|
Secondary Outcome(s)
|
|
Compare the duration of treatment with the control group
[Time Frame: 18 months]
|
|
Assess the overall quality of treatment (American Board of Orthodontics' grading system)
[Time Frame: 18 months]
|
|
Evaluate changes in density and bone volume with the cone beam computed tomography or Cone Beam Computerized Tomography (CBCT)
[Time Frame: 18 months]
|
|
Evaluation of osteoclastic activity (analysis of RANKL and OPG markers by sampling in the gingival fluid with sterile paper points)
[Time Frame: weeks 0, 1, 3, 5, 8, 12, 16, 24]
|
|
Assessment of pain during treatment (numerical visual scale)
[Time Frame: Every days after the surgery durin 7 days and one day after every appointment]
|
|
Evaluation of inflammatory markers (quantification of interleukin-1 (IL-1))
[Time Frame: weeks 0, 1, 3, 5, 8, 12, 16, 24]
|
|
Evaluate the inflammatory and remodelling gene expression
[Time Frame: 0 and 8 weeks]
|
|
Evaluate root resorption with the Cone Beam Computerized Tomography (CBCT)
[Time Frame: 18 months]
|
|
Secondary ID(s)
|
|
UMontreal
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|