Comparison Between the Effectiveness of Different Commercial Bracket Brands

Comparison Between the Effectiveness of Different Commercial Bracket Brands, Having Roth Prescription and 0.022" Bracket Slot: A Randomized Clinical Trial

There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with Class I molar relation and teeth crowding, in which different bracket brands will be compared.

Study Overview

• Status: Recruiting
• Conditions: Crowding, Tooth, Class I
• Intervention / Treatment: Other: Brackets

Detailed Description

Bracket effectiveness can be measured in a variety of ways, including torque, tip, time required for levelling and alignment, bracket failure, and the patient's visual analogue scale. All are viable options; therefore, we want to complete the orthodontic treatment and determine which brackets fulfilled the built-in bracket prescription and achieved success in terms of aesthetics, better smiles, better patient judgement, and function.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salma K. Yacoub; Phone Number: +20 01119174379; Email: 20183314@fue.edu.eg
• Study Contact Backup: Name: Heba M. Dehis, Lecturer; Phone Number: +20 01020490611; Email: heba.dehis@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Future University in Egypt
    • Contact: Leena Alaa; Phone Number: +201123880046

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with full set of permanent teeth
• Male and female (14-19 years old).
• Positive patients' acceptance for the study
• Patients have no history of previous orthodontic treatment.

Exclusion Criteria:

• Patients with enamel or dentin defect or any teeth anomaly will be eliminated.
• Patients having canine or lateral incisors peg shaped will be excluded from the research. - Medically compromised patients
• Patients unable to give an informed consent
• Patient with periodontal disease
• Patient taking long term medication
• Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth Breathing)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: American orthodontics brackets; Roth prescription, 0.022" slot size	Other: Brackets; Levelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics) • After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months)
ACTIVE_COMPARATOR: FANTA brackets; Roth prescription, 0.022" slot size	Other: Brackets; Levelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics) • After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months)
ACTIVE_COMPARATOR: MATT brackets; Roth prescription, 0.022" slot size	Other: Brackets; Levelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics) • After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tip	The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)	From pre to post levelling and alignment (an average of 6 - 8 months)
torque	The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)	3 months after reaching 19x25 stainless steel wire (an average of 6 - 8 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levelling and alignment	The incisal edges of the anterior teeth and the buccal cusps of the posterior teeth are placed on the same horizontal level; and alignment is the lining up of teeth of an arch in order to achieve normal contact point relationships will be assessed by measuring Little's Irregularity Index (LII) using study models taken of the patients (measured in mm)	upto 6 months from the start of orthodontic treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain of intervention	Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10	From pre to post levelling and alignment (an average of 6 - 8 months)

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Director: Yehya A. Mostafa, Professor and Chairman, Future University in Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: VAS; CBCT; orthodontic bracket brands; torque prescription; tip prescription; levelling and Alignment; Lateral Cephalometric Radiographs
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: FUE.REC(32)/12-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Collected IPD
• IPD Sharing Time Frame: Data will be available after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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