Effect of Micro-osteoperforation on the Rate of Canine Retraction

Not Applicable

Completed

• Conditions: Orthodontics
• Interventions: Procedure: micro-osteoperforation

• Registration Number: NCT03450278
• Lead Sponsor: Cairo University

Brief Summary

The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model.

Detailed Description

Sample size calculation was carried out and resulted in enrolment of 18 female patients requiring bilateral upper first premolars extraction and canine retraction with maximum anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.

After placement of the fixed orthodontic appliance, leveling and alignment proceeded till 0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was referred for upper 1st premolars extraction.

Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted and three vertically aligned MOPs were randomly allocated and performed in one side using a single TAD, while the other side served as control. The three MOPs were performed distal to the canine, equidistant in the extraction space. Bilateral canine retraction was then commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the clinic, a pain questionnaire was given to each patient.

Data were collected from monthly upper impressions, which were poured into stone models and scanned to obtain sequential digital models (T0, T1, T2, T3 \& T4), in addition to pre- and post-retraction maxillary CBCT images.

The assessed outcomes were the rate of canine retraction per month, the total distance travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of upper canines and first molars, canine root resorption and finally the pain related to MOP procedure. Statistical analysis was performed on the gathered data and results were withdrawn.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2018-01-03
• Study Completion: 2018-01-10
• Status Verified: 2018-02
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-03-01
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Malocclusion that requires bilateral extraction of the maxillary first premolars and canine retraction with maximum anchorage; Class II division 1 and bimaxillary dentoalveolar protrusion cases.
• Full permanent dentition with exception of the third molars.
• Good oral hygiene and periodontal condition.

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Exclusion Criteria

• Medically compromised patients.
• Patients suffering from any congenital, hereditary or systemic diseases.
• Chronic use of any medications affecting orthodontic tooth movement (e.g. corticosteroids, hormonal therapy, NSAIDs)
• Patients with dental anomalies (e.g. enamel hypoplasia, root dilacerations in maxillary canines).
• Patients with medical conditions that contraindicate surgeries (e.g. bleeding tendency and immunocompromised patients).
• Radiographic evidence of bone loss.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micro-osteoperforation	micro-osteoperforation	canine retraction accelerated with micro-osteoperforation

Primary Outcome Measures

Name	Time	Method
Rate of maxillary canine retraction	4 months of canine retraction	distance (mm) moved by the canine distally per month

Secondary Outcome Measures

Name	Time	Method
Maxillary first molar anchorage loss	4 months of canine retraction	anchorage loss (mesial movement) of the maxillary first molar occuring after 4 months of canine retraction.
Pain caused by the micro-osteoperforation procedure	1 week after the micro-osteoperforation procedure	Pain assessed using the Numeric Pain Rating Scale (0-10) assessed immediately after the micro-osteoperforation (MOP) procedure, 1 day, 3 days and 1 week after the MOP procedure. 0 pain score: no pain, (1-3) pain score: mild pain, (3-6) pain scores: moderate pain, (7-10) pain score: severe pain.
Maxillary canine tipping, torque and rotation	4 months of canine retraction	change in the three dimensional axial inclination (tipping, torque and rotation) of the maxillary canine after 4 months of retraction
Maxillary first molar tipping, torque and rotation	4 months of canine retraction	change in the three-dimensional axial inclination (tipping, torque and rotation) of the maxillary first molar after 4 months of canine retraction.
Maxillary canine root resorption	4 months of canine retraction	amount of canine root resorption occurred after 4 moths of retraction