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Biological Anchorage With Selective Micro-osteoperforations (MOPs) in Canine Distalization

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ClinicalTrials.gov Identifier: NCT03741504
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Sonia Patricia Plaza, Fundación Universitaria CIEO

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE December 2, 2019
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Amount of distal movement of the upper canine [ Time Frame: Change from baseline at three months ]
    Distance from a tangent to a reference point in the palate (third palatal ruga) to the distal side of the upper canine (measured in digital models)
  • Inclination of the upper canine, second premolar and first molar [ Time Frame: Change from baseline at three months ]
    The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
  • Angulation of the upper canine, second premolar and first molar [ Time Frame: Change from baseline at three months ]
    The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
  • Amount of mesial movement of upper first molar [ Time Frame: Change from baseline at three months ]
    Distance from a tangent to a reference point in the palate (third palatal ruga) to the mesial side of the upper first molar (measured in digital models)
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Amount of distal movement of the upper canine [ Time Frame: Change from baseline at three months ]
    Distance from a tangent to a reference point in the palate (mini-implant) to the distal side of the upper canine (measured in digital models)
  • Inclination of the upper canine, second premolar and first molar [ Time Frame: Change from baseline at three months ]
    The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
  • Angulation of the upper canine, second premolar and first molar [ Time Frame: Change from baseline at three months ]
    The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
  • Amount of mesial movement of upper first molar [ Time Frame: Change from baseline at three months ]
    Distance from a tangent to a reference point in the palate (mini-implant) to the mesial side of the upper first molar (measured in digital models)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Periodontal status [ Time Frame: Change from baseline at three months ]
    It's going to be measured by clinical exam
  • Evaluation of the perception of pain by the patient: VAS [ Time Frame: Change from baseline at three months ]
    Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
  • Number of participants with postoperative inflammation and/or infection [ Time Frame: Change from baseline at three months ]
    Inflammation, infection by clinical exam
  • Number of upper canines with external root resorption [ Time Frame: Change from baseline at three months ]
    Periapical radiograph
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Periodontal status [ Time Frame: Change from baseline at three months ]
    It's going to be measured by clinical exam
  • Evaluation of the perception of pain by the patient: VAS [ Time Frame: Change from baseline at three months ]
    Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
  • Postoperative complications [ Time Frame: Change from baseline at three months ]
    Inflammation, infection by clinical exam
  • External root resorption [ Time Frame: Change from baseline at three months ]
    Periapical radiograph
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Anchorage With Selective Micro-osteoperforations (MOPs) in Canine Distalization
Official Title  ICMJE Biological Anchorage With Selective Micro-osteroperforations (MOPs) in Canine Distalization
Brief Summary

To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the mesio-distal inclination of the canine and the messiah movement of the upper first molar.

Methods: Clinical trial with Split mouth design in 35 orthodontic patients with bilateral extraction of the upper first premolar, each upper canine will be randomly assigned to the intervention (MOP) or to the control side. Participants will be followed for 3 months and the investigators will take periapical radiographs, cast models and clinical measurements before and after canine retraction. The measurements will be taken by previously calibrated operators. The results are going to be determined and compared between sides, with the corresponding statistical tests and the results are going to be analyzed.

Detailed Description

PICO QUESTION: ¿Does the amount of distal orthodontic movement of the upper canine increase in the side with MOPs compared with the side without MOPs? Population: Orthodontic patients with bilateral extraction of the upper first premolar (Split mouth design trial) Intervention: Distal movement of the upper canine with Selective MOPs (distal to canine) in one hemi-arch Comparison: Distal movement of the upper canine without MOPs in the other hemi-arch Outcome: Canine and first molar movements

GENERAL AIM:

- To evaluate the effect of selective micro-osteoperforations (MOPs) on the amount of distal movement of the upper canine, the M-D inclination of the canine and the mesial movement of the upper first molar.

METHODS

OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.

  • Randomly assign upper canines in to 2 sides in a split mouth design study: one side to receive intervention (MOPs) and the other side as a control (without MOPs).
  • Then follow both sides for three months
  • Split mouth design method: The investigators are going to randomly assign to the patients' left or right sides, one side for the intervention and the other side for the control (to eliminate the possibility of selection bias).
  • Blinding: It is not possible to blind participants and clinical staff, but the investigators are going to blind the operators who will perform the measurements and the data analysis (single-blinded).

The participants will be with orthodontic fixed appliances (MBT prescription slot 0.022 "x0.028", canine torque 0 °), with working arches 0.019 "x0.025" stainless steel and with bilateral extractions of the first upper premolars for 6 months or more. For this moment the crowding must be resolved and there must be a space of 3 or more millimeters between the canines and second premolars.

The 4 upper incisors will be consolidated with a 0.010 "stainless steel ligature below the arch to prevent opening of anterior spaces.

Observation:

  • No transpalatal arch (TPA) will be used in any of the participants
  • It is going to place a mini-implant in the palate for reference point before the start of the experiment PLANS FOR RECRUITMENT Patients of the Clinic University (UniCIEO) and Antioquia University POTENCIAL CONFOUNDING VARIABLES
  • Age
  • Sex
  • Systemic diseases not reported by the participant
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Teeth Mesial Drift
  • Bone Injury
  • Orthodontic Pathological Resorption of External Root
Intervention  ICMJE Procedure: micro-osteoperforations (MOPs)
three (3) micro-osteoperforations (MOPs) in the cortical and medullar bone, distal to the upper canine. These MOPs will be at the apical, medial and gingival zone of the bone located at the distal surface of the canine in the buccal and in the palatal side. The deep of the MOPs will be at 6 mm. It is going to be done with a PROPEL
Study Arms  ICMJE
  • No Intervention: No micro-osteoperforations (No MOPs)
    Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force
  • Experimental: Micro-osteoperforations (MOPs)
    Canine Distalization with micro-osteoperforations at the start of the distalization Distalization of the upper canine in working phase with coil spring of 100 gr of force
    Intervention: Procedure: micro-osteoperforations (MOPs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2018)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 12, 2021
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Class I or Class II malocclusion, division 1 (ANB: 0º-5º) with maxillary canines completely erupted with the need for canine retraction.
  • Patients in the working phase with MBT prescription, slot 0.022" who have undergone extractions of bilateral upper premolar with more than three months before the time of upper canine distalization and with open space between the canine and the second premolar greater or equal to 3 mm.
  • Age range between 14-40 years.
  • Probing depth less than 4 mm in the upper canine

Exclusion Criteria:

  • Patients with systemic disease.
  • Medicated patients (prolonged use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, corticosteroids, systemic steroids, and calcium channel blockers).
  • Pregnancy.
  • Poor oral hygiene evident in more than two visits.
  • Overjet ≥ 6 mm
  • SN-GoGn ≥ 38 °
  • Radiographic evidence of moderate to severe bone loss.
  • Subjects with active periodontal disease
  • Patients who smoke.
  • Individuals with inadequately treated endodontic problems in the study area.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sonia Plaza, MsD 3183973032 sp.plaza@unicieo.edu.co
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741504
Other Study ID Numbers  ICMJE 042
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data is going to be share only for statistical analysis
Responsible Party Sonia Patricia Plaza, Fundación Universitaria CIEO
Study Sponsor  ICMJE Fundación Universitaria CIEO
Collaborators  ICMJE Universidad de Antioquia
Investigators  ICMJE Not Provided
PRS Account Fundación Universitaria CIEO
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP