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
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.
|Condition or disease||Intervention/treatment||Phase|
|Teeth Mesial Drift Bone Injury Orthodontic Pathological Resorption of External Root||Procedure: micro-osteoperforations (MOPs)||Not Applicable|
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
- 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.
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.
- 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
- Systemic diseases not reported by the participant
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Biological Anchorage With Selective Micro-osteroperforations (MOPs) in Canine Distalization|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||December 12, 2020|
|Estimated Study Completion Date :||June 12, 2021|
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
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
- 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)
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741504
|Contact: Sonia Plaza, MsDfirstname.lastname@example.org|
|Bogotá, DC, Colombia, 110111|
|Contact: Sonia Plaza, MSc|
|Universidad de Antioquia||Recruiting|
|Bogotá, DC, Colombia, 110111|
|Contact: Diana Barbosa, Msc 3168297717 email@example.com|