Efficacy of Twin Arch Brackets in the Control of Orthodontic Tooth Movement (TAB)

October 21, 2021 updated by: Mohammed Basher Farhat, Al-Azhar University

Assessment of the Efficacy of Twin Arch Brackets in the Control of Orthodontic Tooth Movement: A Randomized Controlled Clinical Study

To evaluate the efficacy of twin arch brackets compared to conventional brackets in the control of orthodontic tooth movement.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alignment and leveling of teeth generally constitute the most important preliminary clinical phase of any orthodontic treatment with fixed orthodontic appliances.

During the leveling and alignment stage, tooth movement is directly affected by many factors, such as interbracket distance, bracket width, archwire selection and the friction generated between the bracket and the archwire. It is critical that the force moment which generated by interaction between the bracket slot and the archwire to be transferred from the archwire to the malpositioned tooth.

While it is widely recognized that the geometric structure of the bracket, especially the slot width, determines the efficiency of the force moment, the interbracket span, on the other hand, remains another crucial factor affecting the effectiveness of tooth displacement. It has been established that a sufficient interbracket span enables the flexible archwire to activate its springiness caused by deflection. A wider bracket is favorable to develop an adequate force moment, but the subsequent decrease in the space between the brackets will reduce the effective length of the archwire segments between the supports. As a matter of fact, the efficiency of treatment mechanics is a major focus in modern orthodontics.The advancement of bracket design began with the vertically positioned slot in the ribbon arch appliance to the pure rectangular horizontal slot in the traditional standard edgewise to the modern preadjusted brackets in the straight wire technique, and to the current design of the self-ligating brackets system. It is interesting to note that despite the numerous bracket designs, one feature has remained unchanged: there is only one single horizontal slot on the facial surface of the bracket. In some design variations, such as the Tip- Edge Plus, In-Ovation and " R " brackets, an additional horizontal slot is enclosed within the bracket base and is not open to the labial surface, therefore only allowing for engagement of segmental auxiliary archwires. However some inventors design bracket system called "the twin wire appliance or twin arch wire appliance " which can fit two archwires simultaneously by incorporating two horizontal slots in the design of single brackets. In twin arch appliance design, the bracket width is doubled without decreasing the interbracket span.

The treatment technique to work with two arch wires simultaneously is not new. The idea behind the invention of twin arch appliance was to achieve a better control over orthodontics tooth movements. In the orthodontic literature a very little knowledge and research can be found concerning the use of Twin arch appliance in orthodontic treatment. In the 1930s attempts were made to develop a new treatment method with this concept. Spencer Atkinson was the pioneer, Spencer created a bracket with a vertical and a horizontal slot, positioned one on top of the other. Then in 2008 an experimental study for the efficiency of double slot brackets in correction of malposed teeth when placed in wax typodont was established. The study revealed that twin slot bracket doubles the rate of teeth alignment. The reason behind this phenomenon that the twin-slot bracket doubles the rate of alignment may be attributed to fact that the force applied on the tooth bonded with the twin-slot bracket is doubled and the rate of wax flow is likely to be proportional to load .

Because of the promising results obtained from the previous experimental study and the lack of clinical study results, it will be beneficial to study and compare clinically the effectiveness of twin arch appliance in control of orthodontic tooth movements as well as the comfort of patient during the initial leveling and alignment stage of treatment in relation to other conventional bracket systems.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 11651
        • Al Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age range from 13 to 18 years.
  2. Full set of permanent teeth (the third molars are not considered).
  3. Angle class I malocclusion with normal facial proportions.
  4. Mild to moderate crowding in both arches that require treatment with fixed appliance using non extraction approach
  5. No previous orthodontic or orthognathic surgery treatment.
  6. Free from oral and general health problems that could interfere with orthodontic treatment..
  7. All teeth should be caries-free.

Exclusion Criteria:

  1. Patients with poor oral hygiene or periodontally compromised teeth.
  2. History of serious medical problems or taking systemic medication which could affect orthodontic treatment.
  3. History of serious dental problems (endodontic treatment, periodontal surgery, apicectomy, or any other dental problems) which could affect orthodontic treatment.
  4. History of trauma, bruxism, or or parafunctional habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Twin arch brackets
the malocclusion for this group will be treated using fixed appliance which utilize twin arch brackets system.
Device: Twin Arch Brackets
Twin Arch Brackets characterized by double horizontal slots which make it capable to accept two arch wire at the same time which in turn can achieve a better control over orthodontic tooth movement
Other Names:
  • Preadjusted Edgewise Brackets
Experimental: Conventional brackets
the malocclusion for this group will be treated using fixed appliance which utilize conventional "pre-adjusted edgewise "brackets system.
Device: Twin Arch Brackets
Twin Arch Brackets characterized by double horizontal slots which make it capable to accept two arch wire at the same time which in turn can achieve a better control over orthodontic tooth movement
Other Names:
  • Preadjusted Edgewise Brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of efficacy of Twin Arch brackets in orthodontic tooth movement
Time Frame: 1 years
Time taken for leveling and alignment phase for anterior teeth will be evaluated for each group.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort of Twin Arch brackets .
Time Frame: 1 week
Pain in day 1 to day 7 after brackets and archwires placement will be evaluated for each group of patients.
1 week
Patient acceptance or preference.
Time Frame: 1 year
Patient acceptance or preference for the sight of brackets will be evaluated for each group
1 year
Failure of brackets bonding
Time Frame: 2 years
Number of brackets debonding or fracture during treatment period will be evaluated and recorded monthly for each group of patients
2 years
Oral hygiene maintenance
Time Frame: 1.5 year
Patient capability to keep up with oral hygiene measures and instructions will be evaluated for each group of patients
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Director: Raafat E G Mohamed, Asst Prof, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
  • Study Director: Ahmed S Ammar, Lecturer, Department of Orthodontics, Faculty of Dental Medicine (Boys- Cairo), Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Twin arch brackets

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the research done and I finished my master degree the research will available for the public

IPD Sharing Time Frame

2 - 3 years

IPD Sharing Access Criteria

Via email massages

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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