Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage

Evaluation of Effects of Bracket's Slot System on the Quantity and Quality of Teeth Movements During Orthodontic Leveling and Alignment Stage : A Prospective Clinical Study

Evaluation of effect of bracket slot system on the quality and quantity of tooth movement during leveling and alignment stage

Study Overview

• Status: Enrolling by invitation
• Conditions: Moderate and Severe Crowding in Lower Dental Arch
• Intervention / Treatment: Device: Bracket slot 0.018; Device: Bracket slot 0.022

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Naşr, Cairo, Egypt, 44511
      • Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• An age range from14 to18 years. All permanent teeth are erupted(3rd molar not included).
• Angle class I malocclusion with normal facial proportions.
• Moderate to severe crowding in the lower dental arch asassessed by lett irregularity Index that require treatment with fixed appliance using extraction approach.
• There is no previous orthodontic treatment.

Exclusion Criteria:

• Poor oral hygiene or periodontally compromised teeth.
• Craniofacial anomalies or previous history of trauma, bruxism, or Parafunctions.
• Uncooperativepatient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bracket slot 0.018	Device: Bracket slot 0.018; That includes12 patients who will be treated using the bracket slot 0.018×0.025-inch system.
Active Comparator: Bracket slot 0.022	Device: Bracket slot 0.022; Includes12 patients who will be treated using the bracket slot 0.022×0.028-inch system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tooth movement by different bracket slot system	Amount of tooth movement	At 8 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Alazhar University, Al-Azhar University

Publications and helpful links

General Publications

• Mavragani M, Vergari A, Selliseth NJ, Boe OE, Wisth PL. A radiographic comparison of apical root resorption after orthodontic treatment with a standard edgewise and a straight-wire edgewise technique. Eur J Orthod. 2000 Dec;22(6):665-74. doi: 10.1093/ejo/22.6.665.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2023
• Primary Completion (Anticipated): August 25, 2023
• Study Completion (Anticipated): October 25, 2023

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Alignment; Leveling; Slot 0.018; Slot 0.022; Bracket
• Other Study ID Numbers: 735/1246

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No