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

NCT05071599 | Unknown

• 1 other identifier: Twin arch brackets
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontic Tooth Movement

Keywords

Brackets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comfort of Twin Arch brackets .

  1 week

• Patient acceptance or preference.

  1 year

• Failure of brackets bonding

  2 years

• Oral hygiene maintenance

  1.5 year

Study Arms (2)

Twin arch brackets

EXPERIMENTAL

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

Device: Twin Arch Brackets

Conventional brackets

EXPERIMENTAL

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

Device: Twin Arch Brackets

Interventions

Twin Arch Brackets 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

Also known as: Preadjusted Edgewise Brackets

Conventional brackets; Twin arch brackets

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Nasr City, 11651, Egypt

Location

Related Publications (13)

• 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.

  PMID: 24351147 BACKGROUND

• 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.

  PMID: 22573909 BACKGROUND

• 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.

  PMID: 25707826 BACKGROUND

• 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.

  PMID: 17482074 BACKGROUND

• 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.

  PMID: 18678759 BACKGROUND

• 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.

  PMID: 16637731 BACKGROUND

• 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.

  PMID: 17561042 BACKGROUND

• 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.

  PMID: 17208110 BACKGROUND

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

  PMID: 17347298 BACKGROUND

• 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.

  PMID: 20575195 BACKGROUND

• 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.

  PMID: 24049221 BACKGROUND

• 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.

  PMID: 1059332 BACKGROUND

• 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.

  PMID: 14076341 BACKGROUND

Related Links

• Clinical evaluation of the failure rates of metallic brackets
• A COMPARISON STUDY OF BRACKET FAILURE RATE BETWEEN DIRECT AND INDIRECT BONDING TECHNIQUES

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Mohammed B Farhat, BDS

CONTACT

00201275691981; frahat1991@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 1, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 - 3 years
• Access Criteria: Via email massages

Locations

EG (1)