Orthodontic Tooth MovementTABNCT05071599
Efficacy of Twin Arch Brackets in the Control of Orthodontic Tooth Movement
A study testing Twin Arch Brackets in people with Orthodontic Tooth Movement, run by Al-Azhar University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of twin arch brackets compared to conventional brackets in the control of orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Twin Arch Brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Twin Arch Brackets
- Keywords
- Brackets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin Arch BracketsDevice
Also called Preadjusted Edgewise 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
| Study group | Role | What they receive |
|---|---|---|
| Twin arch brackets | Experimental | the malocclusion for this group will be treated using fixed appliance which utilize twin arch brackets system. Receives: 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. Receives: Device: Twin Arch Brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (4)
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.
Measured: 1 week
Patient acceptance or preference.
Patient acceptance or preference for the sight of brackets will be evaluated for each group
Measured: 1 year
Failure of brackets bonding
Number of brackets debonding or fracture during treatment period will be evaluated and recorded monthly for each group of patients
Measured: 2 years
Oral hygiene maintenance
Patient capability to keep up with oral hygiene measures and instructions will be evaluated for each group of patients
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Basher Farhat, Al-Azhar University
- Investigators
- Raafat E G Mohamed, Asst Prof, Study director, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar UniversityAhmed S Ammar, Lecturer, Study director, Department of Orthodontics, Faculty of Dental Medicine (Boys- Cairo), Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071599
- Sponsor's protocol ID
- Twin arch brackets
- Acronym
- TAB
- Status last verified
- Oct 2021
- First submitted
- 12 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the research done and I finished my master degree the research will available for the public
Publications
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.
PubMed 24351147Sifakakis 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.
PubMed 22573909Khattab 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.
PubMed 25707826Liaw 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.
PubMed 17482074Shen 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.
PubMed 18678759Miles 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.
PubMed 16637731Yeh 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.
PubMed 17561042Rinchuse 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.
PubMed 17208110Parkhouse RC. Current products and practice: Tip-Edge Plus. J Orthod. 2007 Mar;34(1):59-68. doi: 10.1179/146531207225021933.
PubMed 17347298Miles P, Weyant R. Porcelain brackets during initial alignment: are self-ligating cosmetic brackets more efficient? Aust Orthod J. 2010 May;26(1):21-6.
PubMed 20575195Charan 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.
PubMed 24049221Little 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.
PubMed 1059332GREENE 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.
PubMed 14076341
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Twin Arch Brackets in the Control of Orthodontic Tooth Movement: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05071599
- Acronym / sponsor ID
- TAB / Twin arch brackets
- Conditions
- Orthodontic Tooth Movement
- Keywords
- Brackets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of twin arch brackets compared to conventional brackets in the control of orthodontic tooth movement.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twin arch brackets | Experimental | Device: Twin Arch Bracketsthe malocclusion for this group will be treated using fixed appliance which utilize twin arch brackets system. |
| Conventional brackets | Experimental | Device: Twin Arch Bracketsthe malocclusion for this group will be treated using fixed appliance which utilize conventional "pre-adjusted edgewise "brackets system. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twin Arch BracketsAlso: Preadjusted Edgewise BracketsTwin 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 | Device | Conventional brackets, Twin arch brackets |
Primary outcome
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.
4 secondary outcomes
Comfort of Twin Arch brackets .
Time frame: 1 week
Patient acceptance or preference.
Time frame: 1 year
Failure of brackets bonding
Time frame: 2 years
Oral hygiene maintenance
Time frame: 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 24351147Gravina 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.
- Background: PubMed 22573909Sifakakis 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.
- Background: PubMed 25707826Khattab 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.
- Background: PubMed 17482074Liaw 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.
- Background: PubMed 18678759Shen 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.
- Background: PubMed 16637731Miles 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.
- Background: PubMed 17561042Yeh 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.
- Background: PubMed 17208110Rinchuse 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.
- Background: PubMed 17347298Parkhouse RC. Current products and practice: Tip-Edge Plus. J Orthod. 2007 Mar;34(1):59-68. doi: 10.1179/146531207225021933.
- Background: PubMed 20575195Miles P, Weyant R. Porcelain brackets during initial alignment: are self-ligating cosmetic brackets more efficient? Aust Orthod J. 2010 May;26(1):21-6.
- Background: PubMed 24049221Charan 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.
- Background: PubMed 1059332Little 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.
- Clinical evaluation of the failure rates of metallic bracketsLink provided by the sponsor.
- A COMPARISON STUDY OF BRACKET FAILURE RATE BETWEEN DIRECT AND INDIRECT BONDING TECHNIQUESLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. When the research done and I finished my master degree the research will available for the public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raafat E G Mohamed, Asst Prof study director
Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
Ahmed S Ammar, Lecturer study director
Department of Orthodontics, Faculty of Dental Medicine (Boys- Cairo), Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin Arch Brackets in people with Orthodontic Tooth Movement, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed B Farhat, BDS (00201275691981, frahat1991@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of efficacy of Twin Arch brackets in orthodontic tooth movement (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071599, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.