Effect of Micro-osteoperforation on the Rate of Canine Retraction

Effect of Micro-osteoperforation on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthodontics
• Intervention / Treatment: Procedure: micro-osteoperforation

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 Statistical analysis was performed on the gathered data and results were withdrawn.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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; canine retraction without any means of acceleration.
Experimental: micro-osteoperforation; canine retraction accelerated with micro-osteoperforation	Procedure: micro-osteoperforation; Minor surgical procedure including performance of limited and shallow perforations of the cortical plate of bone to increase the expression of inflammatory cytokines, hence accelerating orthodontic tooth movement.; Other Names: alveolocentesis; bone puncturing; flapless corticotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of maxillary canine retraction	distance (mm) moved by the canine distally per month	4 months of canine retraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary first molar anchorage loss	anchorage loss (mesial movement) of the maxillary first molar occuring after 4 months of canine retraction.	4 months of canine retraction
Maxillary canine tipping, torque and rotation	change in the three dimensional axial inclination (tipping, torque and rotation) of the maxillary canine after 4 months of retraction	4 months of canine retraction
Maxillary first molar tipping, torque and rotation	change in the three-dimensional axial inclination (tipping, torque and rotation) of the maxillary first molar after 4 months of canine retraction.	4 months of canine retraction
Maxillary canine root resorption	amount of canine root resorption occurred after 4 moths of retraction	4 months of canine retraction
Pain caused by 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.	1 week after the micro-osteoperforation procedure

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 3, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2015-07-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No