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Comparison Between the Effectiveness of Different Commercial Bracket Brands

Primary Purpose

Crowding, Tooth, Class I

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Brackets

About this trial

This is an interventional treatment trial for Crowding, Tooth, Class I focused on measuring orthodontic bracket brands, torque prescription, tip prescription, levelling and Alignment, Lateral Cephalometric Radiographs, CBCT, VAS

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Future University In EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

American orthodontics brackets

FANTA brackets

MATT brackets

Arm Description

Roth prescription, 0.022" slot size

Outcomes

Primary Outcome Measures

Tip

The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)

torque

The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT05333094

First Posted

April 11, 2022

Last Updated

April 11, 2022

Sponsor

Future University in Egypt

1. Study Identification

Unique Protocol Identification Number

NCT05333094

Brief Title

Comparison Between the Effectiveness of Different Commercial Bracket Brands

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Future University in Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crowding, Tooth, Class I

Keywords

orthodontic bracket brands, torque prescription, tip prescription, levelling and Alignment, Lateral Cephalometric Radiographs, CBCT, VAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Single (Outcomes Assessor) Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

American orthodontics brackets

Arm Type

Active Comparator

Arm Description

Roth prescription, 0.022" slot size

Arm Title

FANTA brackets

Arm Type

Active Comparator

Arm Description

Roth prescription, 0.022" slot size

Arm Title

MATT brackets

Arm Type

Active Comparator

Arm Description

Roth prescription, 0.022" slot size

Intervention Type

Other

Intervention Name(s)

Brackets

Intervention Description

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)

Primary Outcome Measure Information:

Title

Tip

Description

The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)

Time Frame

From pre to post levelling and alignment (an average of 6 - 8 months)

Title

torque

Description

The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)

Time Frame

3 months after reaching 19x25 stainless steel wire (an average of 6 - 8 months)

Secondary Outcome Measure Information:

Title

Levelling and alignment

Description

Time Frame

upto 6 months from the start of orthodontic treatment.

Other Pre-specified Outcome Measures:

Title

Pain of intervention

Description

Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10

Time Frame

From pre to post levelling and alignment (an average of 6 - 8 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Salma K. Yacoub

Phone

01119174379

Ext

+20

20183314@fue.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Heba M. Dehis, Lecturer

Phone

01020490611

Ext

+20

heba.dehis@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yehya A. Mostafa, Professor and Chairman

Organizational Affiliation

Future University in Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Future University In Egypt

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leena Alaa

Phone

+201123880046

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All Collected IPD

IPD Sharing Time Frame

Data will be available after publication

Learn more about this trial

Comparison Between the Effectiveness of Different Commercial Bracket Brands

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