Clinical trial NCT06352996: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm
Official title: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm: A Split-Mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Power Arm Canine Retraction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.

Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction.

Detailed description: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.

Participant and eligibility criteria:

Twenty patients will be recruited from the Department of Orthodontics at Mansoura University Pre-treatment records will be taken including: Intraoral and extraoral photographs, panoramic radiographs, cephalometric radiographs, and study models.

Intervention:

Written and informed consents will be taken from the patients. All patients will start the treatment by bonding fixed appliance (preadjusted edgewise, 0.018-in. slot, Roth prescription). Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment will be performed until reaching 0.017×0.025-in. nickel titanium arch wire. After 4 weeks of using the 0.017×0.025 arch wire, canine retraction phase will be initiated on 0.016×0.022 stainless steel arch wire.

After leveling and alignment, mini-implants will be inserted interradicular between the upper second premolar and upper first molar on each side. The mini-implant will be ligated to upper second premolar for indirect anchorage. The first premolars will be extracted at the same day of mini-implant placement.

Canine retraction will start in the same day of upper first premolar extraction. A nickel titanium closed coil spring will be stretched from the mini-implant to the power arm on one side, while direct retraction from the bracket will be used on the contralateral side. The retraction force will be adjusted to 150g using force gauge.

Eligibility criteria: Inclusion Criteria:

* Class II div 1 patients with age range between 14 to 25 years
* patients indicated for maxillary first premolar extraction
* increased over jet
* mild or no crowding in maxilla
* no previous orthodontic treatment
* no history of periodontal disease or bone loss
* good oral hygiene
* no systemic disease
* absence of canine morphological abnormalities.

Exclusion Criteria:

* patients not indicated for maxillary first premolar extraction
* decreased or no over jet
* moderate or severe crowding in maxilla
* previous orthodontic treatment
* history of periodontal disease or bone loss
* bad oral hygiene
* systemic disease
* canine morphological abnormalities.

Primary outcomes:
measure: Canine tipping
timeFrame: 4 months
measure: Canine mobility
timeFrame: 4 months
measure: Implant stability
timeFrame: 4 months
measure: Pain assessment
timeFrame: 1 week
measure: canine rotation
timeFrame: 4 months
measure: canine retraction rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry Mansoura University
Study officials:
References: