Efficacy of Twin Arch Brackets in the Control of Orthodontic Tooth Movement

NCT ID: NCT05071599

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Twin arch brackets

the malocclusion for this group will be treated using fixed appliance which utilize twin arch brackets system.

Group Type EXPERIMENTAL

Twin Arch Brackets

Intervention Type DEVICE

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

Conventional brackets

the malocclusion for this group will be treated using fixed appliance which utilize conventional "pre-adjusted edgewise "brackets system.

Group Type EXPERIMENTAL

Twin Arch Brackets

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Preadjusted Edgewise Brackets

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Basher Farhat

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raafat E G Mohamed, Asst Prof

Role: STUDY_DIRECTOR

Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University

Ahmed S Ammar, Lecturer

Role: STUDY_DIRECTOR

Department of Orthodontics, Faculty of Dental Medicine (Boys- Cairo), Al-Azhar University

Locations

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Al Azhar University

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohammed B Farhat, BDS

Role: CONTACT

00201275691981

References

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Gravina MA, Brunharo IH, Fraga MR, Artese F, Campos MJ, Vitral RW, Quintao CC. Clinical evaluation of dental alignment and leveling with three different types of orthodontic wires. Dental Press J Orthod. 2013 Nov-Dec;18(6):31-7. doi: 10.1590/s2176-94512013000600006.

Reference Type BACKGROUND
PMID: 24351147 (View on PubMed)

Sifakakis I, Pandis N, Makou M, Eliades T, Katsaros C, Bourauel C. A comparative assessment of torque generated by lingual and conventional brackets. Eur J Orthod. 2013 Jun;35(3):375-80. doi: 10.1093/ejo/cjs029. Epub 2012 May 9.

Reference Type BACKGROUND
PMID: 22573909 (View on PubMed)

Khattab TZ, Hajeer MY, Farah H, Al-Sabbagh R. Maxillary dental arch changes following the leveling and alignment stage with lingual and labial orthodontic appliances: a preliminary report of a randomized controlled trial. J Contemp Dent Pract. 2014 Sep 1;15(5):561-6. doi: 10.5005/jp-journals-10024-1579.

Reference Type BACKGROUND
PMID: 25707826 (View on PubMed)

Liaw YC, Su YY, Lai YL, Lee SY. Stiffness and frictional resistance of a superelastic nickel-titanium orthodontic wire with low-stress hysteresis. Am J Orthod Dentofacial Orthop. 2007 May;131(5):578.e12-8. doi: 10.1016/j.ajodo.2006.08.015.

Reference Type BACKGROUND
PMID: 17482074 (View on PubMed)

Shen G, Chen RJ, Hu Z, Qian YF. The effects of a newly designed twin-slot bracket on severely malpositioned teeth--a typodont experimental study. Eur J Orthod. 2008 Aug;30(4):401-6. doi: 10.1093/ejo/cjn011.

Reference Type BACKGROUND
PMID: 18678759 (View on PubMed)

Miles PG, Weyant RJ, Rustveld L. A clinical trial of Damon 2 vs conventional twin brackets during initial alignment. Angle Orthod. 2006 May;76(3):480-5. doi: 10.1043/0003-3219(2006)076[0480:ACTODV]2.0.CO;2.

Reference Type BACKGROUND
PMID: 16637731 (View on PubMed)

Yeh CL, Kusnoto B, Viana G, Evans CA, Drummond JL. In-vitro evaluation of frictional resistance between brackets with passive-ligation designs. Am J Orthod Dentofacial Orthop. 2007 Jun;131(6):704.e11-22. doi: 10.1016/j.ajodo.2006.09.041.

Reference Type BACKGROUND
PMID: 17561042 (View on PubMed)

Rinchuse DJ, Rinchuse DJ, Kapur-Wadhwa R. Orthodontic appliance design. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):76-82. doi: 10.1016/j.ajodo.2005.04.039. No abstract available.

Reference Type BACKGROUND
PMID: 17208110 (View on PubMed)

Parkhouse RC. Current products and practice: Tip-Edge Plus. J Orthod. 2007 Mar;34(1):59-68. doi: 10.1179/146531207225021933.

Reference Type BACKGROUND
PMID: 17347298 (View on PubMed)

Miles P, Weyant R. Porcelain brackets during initial alignment: are self-ligating cosmetic brackets more efficient? Aust Orthod J. 2010 May;26(1):21-6.

Reference Type BACKGROUND
PMID: 20575195 (View on PubMed)

Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

Reference Type BACKGROUND
PMID: 24049221 (View on PubMed)

Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.

Reference Type BACKGROUND
PMID: 1059332 (View on PubMed)

GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

Reference Type BACKGROUND
PMID: 14076341 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3894768/

Clinical evaluation of the failure rates of metallic brackets

https://ajdsm.journals.ekb.eg/article_108468_7c1e0df081158d3f51a0f82c688d143c.pdf

A COMPARISON STUDY OF BRACKET FAILURE RATE BETWEEN DIRECT AND INDIRECT BONDING TECHNIQUES

Other Identifiers

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Twin arch brackets

Identifier Type: -

Identifier Source: org_study_id