The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction

NCT06481761 | Recruiting

• 1 other identifier: Orth3-3-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rate of Canine Retraction

Keywords

canine retraction; double slot brackets; Orthodontic tooth movement

Outcome Measures

Primary Outcomes (1)

• rate of canine retraction

  millimeters through superimposed digital models taken for each patient monthly at the follow up visits.

  3 months

Secondary Outcomes (2)

• Amount of canine root movement

  3 months

• Molar cusp anchorage loss

  3 months

Study Arms (2)

Single-slot brackets

ACTIVE COMPARATOR

Bonding of the upper arch up to second molars with Roth prescription 0.022x.028" single slot brackets (MINI MS-American orthodontics)

Device: Single-slot brackets

Double-slot brackets

EXPERIMENTAL

Double slot brackets (SORTECH-South Orthodontic Technology) will be Bonded on the upper arch up to the second molars. The brackets are of Roth prescription \& have two slots, cervical 0.018x.025" slot and incisal/occlusal 0.022x.028" slot

Device: Double-slot brackets

Interventions

Double-slot brackets DEVICE

Miniscrews will be inserted in the buccal alveolar bone between first and second molars bilaterally and ligated to second premolar. Canine Retraction using Nickel titanium closed-coil springs delivering a force of 150 gram, extending the spring between the canine and first molar hooks. retraction on double 0.016'' Stainless steel round wires in both slots of the double slot brackets. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study.

Double-slot brackets

Single-slot brackets DEVICE

Miniscrews will be inserted in the buccal alveolar bone between first and second molars bilaterally and ligated to second premolar. Canine Retraction using Nickel titanium closed-coil springs delivering a force of 150 gram, extending the spring between the canine and first molar hooks. retraction on single 0.017x0.022'' Stainless steel wire. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study.

Single-slot brackets

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

RECRUITING

Study Officials

• Amr R El Beialy, Assoc.Prof

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY CHAIR

• Nada O El Zawahry, lecturer

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Noha A El Ashmawi, lecturer

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Raghad M ghoneim, BDS

CONTACT

1066245394; Raghad.gouda@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, neither participants nor investigators can be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: study is a randomized clinical trial, single-center, parallel group, two-arms with 1:1 allocation ratio

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

EG (1)