Clinical trial NCT06481761: The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction
Official title: The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rate of Canine Retraction
Keywords: canine retraction
double slot brackets
Orthodontic tooth movement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study is a randomized clinical trial, single-center, parallel group, two-arms with 1:1 allocation ratio
Primary purpose: TREATMENT

Brief summary: The aim of this Randomized clinical trial is to compare the efficacy of the double slot brackets compared to single slot-brackets in producing a controlled rate of upper canine retraction into premolar extraction space.

patients will be randomly divided into one of the two groups, CBCT (cone beam computed tomography) and dental models will be taken for each patient Pre-retraction and following the study completion.

The rate of retraction will be evaluated for both groups as well as Amount of canine root movement and molar anchorage loss will be also assessed.

Detailed description: Eligible patients will be examined for fulfilling the inclusion criteria. All the recruited patients need extraction of upper first premolars followed by canine retraction with maximum anchorage.

The patients will be randomly allocated to one of the two groups; either Double slot brackets or single slot-brackets group.

In Double slot bracket group, Canine retraction will be made on two 0.016'' StSt (stainless steel) round wires, each in one of the slots of the double slot brackets. while in single slot-bracket group, Retraction will be made on one 0.017''×0.025'' rectangular StSt arch wire .

The patients will be seen on a monthly basis for follow up visit for reactivation of retraction to maintain constant force during the study. An impression will be taken for the patients every visit, fabricated dental models will be digitally scanned. The scanned models will be used to monitor the rate of canine retraction.

Every patient will be asked to take a CBCT image of the upper arch pre Retraction and after the completion of study duration (3 months). After data collection, assessors will carry on the measurements blindly. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for canine retraction.

Eligibility criteria: Inclusion Criteria:

* Good oral hygiene.
* Adult Male or Female patients with an age range of 16-26 years old.
* Full set of permanent dentition(excluding third molar).
* Any kind of malocclusion requiring first premolar extraction and canine retraction.
* Patients with type/pattern of crowding that allows leveling and alignment before premolar extraction

Exclusion Criteria:

* History of previous orthodontic treatment.
* Craniofacial deformity.
* Systematic disease or administrating drugs affecting tooth movement.
* Poor oral health.

Primary outcomes:
measure: rate of canine retraction
timeFrame: 3 months
Secondary outcomes:
measure: Amount of canine root movement
timeFrame: 3 months
measure: Molar cusp anchorage loss
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Amr R El Beialy, Assoc.Prof
role: STUDY_CHAIR
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Nada O El Zawahry, lecturer
role: STUDY_DIRECTOR
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Noha A El Ashmawi, lecturer
role: STUDY_DIRECTOR
References: