Effect of Micro-osteoperforation on the Rate of Canine Retraction

NCT03450278 | Completed DMC

• 1 other identifier: CEBD-CU-2015-07-10
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

• Rate of maxillary canine retraction

  distance (mm) moved by the canine distally per month

  4 months of canine retraction

Secondary Outcomes (5)

• Maxillary first molar anchorage loss

  4 months of canine retraction

• Maxillary canine tipping, torque and rotation

  4 months of canine retraction

• Maxillary first molar tipping, torque and rotation

  4 months of canine retraction

• Maxillary canine root resorption

  4 months of canine retraction

• Pain caused by the micro-osteoperforation procedure

  1 week after the micro-osteoperforation procedure

Study Arms (2)

control

NO INTERVENTION

canine retraction without any means of acceleration.

micro-osteoperforation

EXPERIMENTAL

canine retraction accelerated with micro-osteoperforation

Procedure: micro-osteoperforation

Interventions

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.

Also known as: alveolocentesis, bone puncturing, flapless corticotomy

micro-osteoperforation

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Dr. Amira Ahmed Mohamed Anis Aboalnaga

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 1, 2018
• Study Start: December 1, 2015
• Primary Completion: January 3, 2018
• Study Completion: January 10, 2018
• Last Updated: March 1, 2018

Record last verified: 2018-02