Effect of Micro-osteoperforation on the Rate of Canine Retraction

Orthodontics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450278
• Other study ID #: CEBD-CU-2015-07-10
• Status: Completed
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 27, 2018
• Start date: December 2015
• Est. completion date: January 10, 2018

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 10, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontics

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of maxillary canine retraction	distance (mm) moved by the canine distally per month	4 months of canine retraction
Secondary	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
Secondary	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
Secondary	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
Secondary	Maxillary canine root resorption	amount of canine root resorption occurred after 4 moths of retraction	4 months of canine retraction
Secondary	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