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

Orthodontic Tooth Movement Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05071599
• Other study ID #: Twin arch brackets
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Al-Azhar University
• Contact: Mohammed B Farhat, BDS
• Phone: 00201275691981
• Email: frahat1991[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

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

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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. Review. — View Citation

Gravina MA, Brunharo IH, Fraga MR, Artese F, Campos MJ, Vitral RW, Quintão 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. — View Citation

GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. — View Citation

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. — View Citation

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. — View Citation

Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. — View Citation

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. — View Citation

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. — View Citation

Parkhouse RC. Current products and practice: Tip-Edge Plus. J Orthod. 2007 Mar;34(1):59-68. — View Citation

Rinchuse DJ, Rinchuse DJ, Kapur-Wadhwa R. Orthodontic appliance design. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):76-82. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of efficacy of Twin Arch brackets in orthodontic tooth movement	Time taken for leveling and alignment phase for anterior teeth will be evaluated for each group.	1 years
Secondary	Comfort of Twin Arch brackets .	Pain in day 1 to day 7 after brackets and archwires placement will be evaluated for each group of patients.	1 week
Secondary	Patient acceptance or preference.	Patient acceptance or preference for the sight of brackets will be evaluated for each group	1 year
Secondary	Failure of brackets bonding	Number of brackets debonding or fracture during treatment period will be evaluated and recorded monthly for each group of patients	2 years
Secondary	Oral hygiene maintenance	Patient capability to keep up with oral hygiene measures and instructions will be evaluated for each group of patients	1.5 year

External Links

•   A COMPARISON STUDY OF BRACKET FAILURE RATE BETWEEN DIRECT AND INDIRECT BONDING TECHNIQUES
•   Clinical evaluation of the failure rates of metallic brackets
•   William R. Proffit,Contemporary Orthodontics, 4th ed. as a reference for leveling and alignment phase