Clinical trial NCT04905004: Efficiency of Canine Retraction Using Different Reactivation Intervals
Official title: Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Class III Malocclusion
Bimaxillary Protrusion
Crowding, Tooth
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 56
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.

Detailed description: The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
* Erupted full set of permanent teeth (excluding 3rd molars)

Exclusion Criteria:

* Systemic diseases that would interfere with bone metabolism
* Craniofacial syndromes
* congenitally missing or extracted permanent teeth.
* periodontally compromised patients
* smokers
* pregnant women
* previous orthodontic treatment

Primary outcomes:
measure: Rate of canine retraction
timeFrame: Baseline to 1 month
measure: Rate of canine retraction
timeFrame: 1month to 2 months
measure: Rate of canine retraction
timeFrame: 2 months to 3 months
measure: Rate of canine retraction
timeFrame: 3 months to 4 months
measure: Rate of canine retraction
timeFrame: 4 months to 5 months
measure: Rate of canine retraction
timeFrame: 5 months to 6 months.
Secondary outcomes:
measure: Amount of canine retraction
timeFrame: Baseline to 6 months
measure: Canine tipping
timeFrame: Baseline to 6 months
measure: Canine rotation
timeFrame: Baseline to 6 months
measure: Canine root resorption
timeFrame: Baseline to 6 months
measure: First molar anchorage loss
timeFrame: Baseline to 6 months
measure: Pain score
timeFrame: baseline to day 1
measure: Pain score
timeFrame: Baseline to day 2
measure: Pain score
timeFrame: Baseline to day 3
measure: Pain score
timeFrame: Baseline to day 4
measure: Pain score
timeFrame: Baseline to day 5
measure: Pain score
timeFrame: Baseline to day 6
measure: Pain score
timeFrame: Baseline to day 7
measure: Pain score
timeFrame: Baseline to day 8
measure: Pain score
timeFrame: Baseline to day 9
measure: Pain score
timeFrame: Baseline to day 10.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future University in Egypt
Study officials:
affiliation: Future University in Egypt
name: Yehya Mostafa, PhD
role: STUDY_DIRECTOR
References: