An interventional study of micro-osteoperforations (MOPs) in Teeth Mesial Drift, Bone Injury and Orthodontic Pathological Resorption of External Root, sponsored by Fundación Universitaria CIEO. Terminated at 2 sites in Colombia. Open to participants aged 14 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-12.
Sponsored by Fundación Universitaria CIEO · Not applicable, Interventional, and Treatment
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.
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:
METHODS
OVERVIEW OF DESIGN Study Design: Randomized controlled clinical trial in split mouth design.
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:
Fundación Universitaria CIEO is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force
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
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)
Time frame: Change from baseline at three months
Inclination of the upper canine, second premolar and first molar
The angle between the long axis of the clinical crown and the reference plane the occlusal plane.(measured in digital models)
Time frame: Change from baseline at three months
Angulation of the upper canine, second premolar and first molar
The long axis of the posterior buccal surface is going to be measured relative to the occlusal plane (measured in digital models)
Time frame: Change from baseline at three months
Amount of mesial movement of upper first molar
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)
Time frame: Change from baseline at three months
Periodontal status
It's going to be measured by clinical exam
Time frame: Change from baseline at three months
Evaluation of the perception of pain by the patient: VAS
Pain visual analogue scale (AVS) - from 0 to 10 points, Higher values represent more pain perception by the participant
Time frame: Change from baseline at three months
Number of participants with postoperative inflammation and/or infection
Inflammation, infection by clinical exam
Time frame: Change from baseline at three months
Number of upper canines with external root resorption
Periapical radiograph
Time frame: Change from baseline at three months
Plan to share: No — Individual participant data is going to be share only for statistical analysis
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Mar 2021, 15 months.
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This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Mesial Movement of Teeth
Fundación Universitaria CIEO