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Completed

NCT Number: NCT03450278

Effect of Micro-osteoperforation on the Rate of Canine Retraction

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.

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Key information

Conditions

Age range

16 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 Statistical analysis was performed on the gathered data and results were withdrawn.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

micro-osteoperforation

Procedure

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

Primary outcomes

  1. Rate of maxillary canine retraction

    Time frame: 4 months of canine retraction

    distance (mm) moved by the canine distally per month

Secondary outcomes

  1. Maxillary first molar anchorage loss

    Time frame: 4 months of canine retraction

    anchorage loss (mesial movement) of the maxillary first molar occuring after 4 months of canine retraction.

  2. Maxillary canine tipping, torque and rotation

    Time frame: 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

  3. Maxillary first molar tipping, torque and rotation

    Time frame: 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.

  4. Maxillary canine root resorption

    Time frame: 4 months of canine retraction

    amount of canine root resorption occurred after 4 moths of retraction

  5. Pain caused by the micro-osteoperforation procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2018
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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