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

NCT03741504 | Terminated

• 1 other identifier: 042
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Teeth Mesial Drift; Bone Injury; Orthodontic Pathological Resorption of External Root

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  Change from baseline at three months

Secondary Outcomes (4)

• Periodontal status

  Change from baseline at three months

• Evaluation of the perception of pain by the patient: VAS

  Change from baseline at three months

• Number of participants with postoperative inflammation and/or infection

  Change from baseline at three months

• Number of upper canines with external root resorption

  Change from baseline at three months

Study Arms (2)

No micro-osteoperforations (No MOPs)

NO INTERVENTION

Canine Distalization without micro-osteoperforations Distalization of the upper canine in working phase with coil spring of 100 gr of force

Micro-osteoperforations (MOPs)

EXPERIMENTAL

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)

Interventions

micro-osteoperforations (MOPs) PROCEDURE

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

Micro-osteoperforations (MOPs)

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead
• Universidad de Antioquia: collaborator

Study Sites (2)

UniCIEO

Bogotá, DC, 110111, Colombia

Location

Universidad de Antioquia

Bogotá, DC, 110111, Colombia

Location

MeSH Terms

Conditions

Mesial Movement of Teeth

Condition Hierarchy (Ancestors)

Tooth Migration; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator Orthodontic Department

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 15, 2018
• Study Start: December 2, 2019
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)