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Clinical Trials/NCT03450278
NCT03450278CompletedNot Applicable

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

Cairo University0 sites36 target enrollmentStarted: December 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Primary Endpoint
Rate of maxillary canine retraction

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 30 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

control

No Intervention

canine retraction without any means of acceleration.

micro-osteoperforation

Experimental

canine retraction accelerated with micro-osteoperforation

Intervention: micro-osteoperforation (Procedure)

Outcomes

Primary Outcomes

Rate of maxillary canine retraction

Time Frame: 4 months of canine retraction

distance (mm) moved by the canine distally per month

Secondary Outcomes

  • Maxillary canine tipping, torque and rotation(4 months of canine retraction)
  • Maxillary first molar anchorage loss(4 months of canine retraction)
  • Pain caused by the micro-osteoperforation procedure(1 week after the micro-osteoperforation procedure)
  • Maxillary first molar tipping, torque and rotation(4 months of canine retraction)
  • Maxillary canine root resorption(4 months of canine retraction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amira Aboalnaga

Assistant Lecturer, Dr. Amira Ahmed Mohamed Anis Aboalnaga

Cairo University

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