Class I MalocclusionNCT05882526
Compartive Evalution of the Efficiency of Maxillary Canine Retraction Using Power Chain Versus Burstone T-loop
A study testing BURSTONE T-LOOP in people with Class I Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
evaluate and compare the efficiency between elastomeric chains and burston T-loop retractors in terms of rate of maxillary canine retraction and canine movements Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Class I Malocclusion
- What is being tested?
- BURSTONE T-LOOP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to Dec 2024
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class I or bimaxillary protursion , orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.
Who cannot join
- Orthodontic cases that could be treated with no indication for extraction therapy.
- 2- Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evalutaion of the Efficiency of Maxillary Canine Retraction Using Orthodontic Elastomeric Chain Versus Burstone T-loop.A Clinical Study
evaluate and compare the efficiency between elastomeric chains and burston T-loop retractors in terms of rate of maxillary canine retraction and canine movements
Read the detailed description
The purpose of orthodontic treatment is to move teeth as efficiently as possible with minimal adverse effects on teeth and supporting tissue. Numerous methods of canine retraction are currently in common use. Force can be applied through the elastics, closed coil springs, wire loops of numerous designs, and a number of headgear types currently available.
The principles for retraction currently used in preadjusted edgewise mechanics can be described as either:(a) a frictional system in which the canine is expected to slide distally along a continuous archwire, (b) frictionless mechanics in which loops (springs) are incorporated in a continuous or a segmental archwire to retract teeth. The sliding mechanism in any application other than simple tipping movement has two disadvantages: (i) friction (ii)force magnitudes cannot be easily determined since the amount of friction is relatively unknown and unpredictable.1 Space closure in orthodontics is the second stage incomprehensive fixed appliance treatment and can be accomplished by either sliding mechanics or loop mechanics. Nickel-titanium closed-coil springs and elastomeric power chains (PC) are the most common force delivery systems used in space closure
In vitro studies of the properties of PC showed that they lose force much more rapidly than springs over time.2-3In addition, environmental factors and temperature have greater effects on the properties of PC than on CS.4 Arch-length-to-tooth-mass discrepancy patients require extraction of teeth and closure of those spaces to correct their malocclusion. There are different mechanical methods used in orthodontic practice to move teeth, such as using various types of elastic materials and coil springs5During the past few years, elastomeric power chains (EPCs) have been used in preference to other retraction orthodontic materials because of their elastic properties, ease of application and requiring no patient co-operation, low cost, being relatively hygienic, and their irritation-free nature due to their smooth surface6 The proper position of canines shares a very important role in oral function and esthetics. Their unique position makes their orthodontic movement of great clinical importance, especially in premolar extraction cases. Segmented arch technique is a modified edgewise orthodontic procedure developed by Burstone7 in 1962 which consists of multiple wires found in different portions of arch. The force systems are relatively constant and with long ranges of activation and optimum force levels their resulting movement is predictable, as stated by Burstone, Baldwin, Lawless.8 Later in 1966, Burstone CJ9 stated that moment-to-force ratio, magnitude of force and the constancy of force determine the success of an appliance. The segmented arch technique has many advantages like better control over the forces, more efficient tooth movement over long distances with light constant forces, as stated by Burstone, Koenig (1976).10 In 1980, Burstone and Goldberg11 introduced beta titanium molybdenum alloy (TMA) wire (11%molybdenum, 6% zirconium and 6% beta titanium alloy) which showed twice the amount of deflection and delivered half the amount of force as compared to stainless steel wires. Burstone, van Steenbergen, Hanley12 in 1995 mentioned that T-loops had three important characteristics, i.e."α" , i.e. anterior moment or β, i.e. posterior moment and a horizontal moment.
Viecilli (2006)13 stated that the effects of steps, angles and vertical forces could be combined to produce an ideal T-loop design. According to Proffit (2007),14 segmented retraction of canines with frictionless springs reduces the strain on posterior teeth. The T-loop design generally provides a constant moment:force (M:F) ratio, a light and constant force throughout the entire activation range of a closing loop, and a constant low load-deflection rate15
Canine retraction and space closure is considered the most time-consuming phase in orthodontic treatment.16 Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects.17,18 Manipulation of tooth biomechanics16-19and tissue reaction20 have been widely attempted to reduce treatment duration. Additionally, the rate and safety of different canine retraction methods20 and different force Various techniques for canine retraction have been introduced including Nickel Titanium closing coil, Elastomeric chains, and lace backs. On the other hand, frictionless mechanics imply the use of the sectional method as the use of Burstone's T - loop, Rickett's spring, or Gjessing's spring Researchers were interested in investigating the effect of different force levels on the rate of canine retraction using sectional springs. And many authors have described various designs of canine retraction springs, their suitability and efficiency 21,22
- Conditions
- Class I Malocclusion
- Being tested
- BURSTONE T-LOOP
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BURSTONE T-LOOPDevice
Also called elastomeric power chain
Split mouth study one side using elastomeric power chain and other side using T loops
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of elastomeric power chain for orthodontic maxillary canine retraction | Active comparator | 20 Orthodontic patient treated by for elastomeric power chain canine retraction split mouth. Receives: Device: BURSTONE T-LOOP |
| Evaluation of T loop for orthodontic maxillary canine retraction | Active comparator | 20 Orthodontic patient treated by T loop for canine retraction split mouth Receives: Device: BURSTONE T-LOOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of canine retraction
distance which canine move pre and post retraction
Measured: FOUR months
Canine rotation
angulation of canine
Measured: 4 MONTH
canine tipping
canine movement in mesial and dISTAL
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start15 May 2023
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Class I MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Evaluation of T loop for orthodontic maxillary canine retraction Evaluation of POWER CHAIN for orthodontic maxillary canine retraction
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelaziz Abdelaziz younes, Mansoura University
- Investigators
- AHMED MAHER FOUDA, Study chair, Mansoura Universitynehal fouad elbelasy, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882526
- Sponsor's protocol ID
- canine retraction in tooth
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barsoum HA, ElSayed HS, El Sharaby FA, Palomo JM, Mostafa YA. Comprehensive comparison of canine retraction using NiTi closed coil springs vs elastomeric chains. Angle Orthod. 2021 Jul 1;91(4):441-448. doi: 10.2319/110620-916.1.
PubMed 34181721Davis S, Sundareswaran S, James J. Comparative evaluation of the efficiency of canine retraction using modified Marcotte and T-loop retraction springs - A split-mouth, randomized clinical trial. J Orthod Sci. 2019 May 23;8:9. doi: 10.4103/jos.JOS_101_18. eCollection 2019.
PubMed 31161132
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evalutaion of the Efficiency of Maxillary Canine Retraction Using Orthodontic Elastomeric Chain Versus Burstone T-loop.A Clinical Study
- ClinicalTrials.gov ID
- NCT05882526
- Acronym / sponsor ID
- canine retraction in tooth
- Conditions
- Class I Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 May 2023 (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.
evaluate and compare the efficiency between elastomeric chains and burston T-loop retractors in terms of rate of maxillary canine retraction and canine movements
Detailed description
The purpose of orthodontic treatment is to move teeth as efficiently as possible with minimal adverse effects on teeth and supporting tissue. Numerous methods of canine retraction are currently in common use. Force can be applied through the elastics, closed coil springs, wire loops of numerous designs, and a number of headgear types currently available.
The principles for retraction currently used in preadjusted edgewise mechanics can be described as either:(a) a frictional system in which the canine is expected to slide distally along a continuous archwire, (b) frictionless mechanics in which loops (springs) are incorporated in a continuous or a segmental archwire to retract teeth. The sliding mechanism in any application other than simple tipping movement has two disadvantages: (i) friction (ii)force magnitudes cannot be easily determined since the amount of friction is relatively unknown and unpredictable.1 Space closure in orthodontics is the second stage incomprehensive fixed appliance treatment and can be accomplished by either sliding mechanics or loop mechanics. Nickel-titanium closed-coil springs and elastomeric power chains (PC) are the most common force delivery systems used in space closure
In vitro studies of the properties of PC showed that they lose force much more rapidly than springs over time.2-3In addition, environmental factors and temperature have greater effects on the properties of PC than on CS.4 Arch-length-to-tooth-mass discrepancy patients require extraction of teeth and closure of those spaces to correct their malocclusion. There are different mechanical methods used in orthodontic practice to move teeth, such as using various types of elastic materials and coil springs5During the past few years, elastomeric power chains (EPCs) have been used in preference to other retraction orthodontic materials because of their elastic properties, ease of application and requiring no patient co-operation, low cost, being relatively hygienic, and their irritation-free nature due to their smooth surface6 The proper position of canines shares a very important role in oral function and esthetics. Their unique position makes their orthodontic movement of great clinical importance, especially in premolar extraction cases. Segmented arch technique is a modified edgewise orthodontic procedure developed by Burstone7 in 1962 which consists of multiple wires found in different portions of arch. The force systems are relatively constant and with long ranges of activation and optimum force levels their resulting movement is predictable, as stated by Burstone, Baldwin, Lawless.8 Later in 1966, Burstone CJ9 stated that moment-to-force ratio, magnitude of force and the constancy of force determine the success of an appliance. The segmented arch technique has many advantages like better control over the forces, more efficient tooth movement over long distances with light constant forces, as stated by Burstone, Koenig (1976).10 In 1980, Burstone and Goldberg11 introduced beta titanium molybdenum alloy (TMA) wire (11%molybdenum, 6% zirconium and 6% beta titanium alloy) which showed twice the amount of deflection and delivered half the amount of force as compared to stainless steel wires. Burstone, van Steenbergen, Hanley12 in 1995 mentioned that T-loops had three important characteristics, i.e."α" , i.e. anterior moment or β, i.e. posterior moment and a horizontal moment.
Viecilli (2006)13 stated that the effects of steps, angles and vertical forces could be combined to produce an ideal T-loop design. According to Proffit (2007),14 segmented retraction of canines with frictionless springs reduces the strain on posterior teeth. The T-loop design generally provides a constant moment:force (M:F) ratio, a light and constant force throughout the entire activation range of a closing loop, and a constant low load-deflection rate15
Canine retraction and space closure is considered the most time-consuming phase in orthodontic treatment.16 Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects.17,18 Manipulation of tooth biomechanics16-19and tissue reaction20 have been widely attempted to reduce treatment duration. Additionally, the rate and safety of different canine retraction methods20 and different force Various techniques for canine retraction have been introduced including Nickel Titanium closing coil, Elastomeric chains, and lace backs. On the other hand, frictionless mechanics imply the use of the sectional method as the use of Burstone's T - loop, Rickett's spring, or Gjessing's spring Researchers were interested in investigating the effect of different force levels on the rate of canine retraction using sectional springs. And many authors have described various designs of canine retraction springs, their suitability and efficiency 21,22
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of T loop for orthodontic maxillary canine retraction Evaluation of POWER CHAIN for orthodontic maxillary canine retraction
| Arm | Type | Receives |
|---|---|---|
| Evaluation of elastomeric power chain for orthodontic maxillary canine retraction | Active comparator | Device: BURSTONE T-LOOP20 Orthodontic patient treated by for elastomeric power chain canine retraction split mouth. |
| Evaluation of T loop for orthodontic maxillary canine retraction | Active comparator | Device: BURSTONE T-LOOP20 Orthodontic patient treated by T loop for canine retraction split mouth |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Class I or bimaxillary protursion , orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.
Key exclusion criteria (2 listed)
- Orthodontic cases that could be treated with no indication for extraction therapy.
- 2- Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.
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 |
|---|---|---|
| BURSTONE T-LOOPAlso: elastomeric power chainSplit mouth study one side using elastomeric power chain and other side using T loops | Device | Evaluation of T loop for orthodontic maxillary canine retraction, Evaluation of elastomeric power chain for orthodontic maxillary canine retraction |
Primary outcome
rate of canine retraction
Time frame: FOUR months
distance which canine move pre and post retraction
Canine rotation
Time frame: 4 MONTH
angulation of canine
canine tipping
Time frame: 4 month
canine movement in mesial and dISTAL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Results publication: PubMed 34181721Barsoum HA, ElSayed HS, El Sharaby FA, Palomo JM, Mostafa YA. Comprehensive comparison of canine retraction using NiTi closed coil springs vs elastomeric chains. Angle Orthod. 2021 Jul 1;91(4):441-448. doi: 10.2319/110620-916.1.
- Results publication: PubMed 31161132Davis S, Sundareswaran S, James J. Comparative evaluation of the efficiency of canine retraction using modified Marcotte and T-loop retraction springs - A split-mouth, randomized clinical trial. J Orthod Sci. 2019 May 23;8:9. doi: 10.4103/jos.JOS_101_18. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
AHMED MAHER FOUDA study chair
Mansoura University
nehal fouad elbelasy study director
Mansoura 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 BURSTONE T-LOOP in people with Class I Malocclusion, run by Mansoura 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 1 inclusion and 2 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 31 May 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of canine retraction (time frame: FOUR months). The study lists 3 primary outcomes in all. 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 NCT05882526, which also lists 2 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 31 May 2023.