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

NCT ID: NCT06481761

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-01-31

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.

Conditions

Rate of Canine Retraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-slot brackets

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

Group Type: ACTIVE_COMPARATOR

Single-slot brackets

Intervention Type: 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.

Double-slot brackets

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

Group Type: EXPERIMENTAL

Double-slot brackets

Intervention Type: 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.

Interventions

Double-slot brackets

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.

Intervention Type: DEVICE

Single-slot brackets

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Raghad Mohsen Ghoneim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr R El Beialy, Assoc.Prof

Role: STUDY_CHAIR

Orthodontic department, Faculty of Dentistry, Cairo University

Nada O El Zawahry, lecturer

Role: STUDY_DIRECTOR

Orthodontic department, Faculty of Dentistry, Cairo University

Noha A El Ashmawi, lecturer

Role: STUDY_DIRECTOR

Orthodontic department, Faculty of Dentistry, Cairo University

Locations

Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Raghad M ghoneim, BDS

Role: CONTACT

Raghad.gouda@dentistry.cu.edu.eg

1066245394 ext. 20

Facility Contacts

cairo university

Role: primary

1203330743 ext. 20

Other Identifiers

Orth3-3-2

Identifier Type: -

Identifier Source: org_study_id