En-masse Retraction , Class I Bimaxillary ProtrusionNCT03261024
Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients
A study testing Friction mechanics and Frictionless mechanics in people with En-masse Retraction , Class I Bimaxillary Protrusion, run by Cairo University.
Trial summary
This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- En-masse Retraction , Class I Bimaxillary Protrusion
- What is being tested?
- Friction mechanics and Frictionless mechanics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Jan 2019
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adult patients with age range 18-30 yrs old.
- Class I bimaxillary dentoalveolar protrusion .
- Full permanent dentition.
- Good oral hygiene.
- Maximum anchorage is required.
- Healthy bone between first molars and second premolars is needed.
Who cannot join
- Systemic disease.
- Severe crowding.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Any signs or symptoms or previous history of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients With Class I Bimaxillary Dentoalveolar Protrusion: A Randomized Clinical Trial
This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.
Read the detailed description
Adult patients with Class I bimaxillary dentoalveolar protrusion will be recruited. All the patients need extraction of upper first premolars followed by anterior segment retraction and maximum anchorage.
The patients will be randomly allocated to one of two groups; either Friction or Frictionless group. In friction group, Nickel Titanium coil spring will be used for retraction of anterior segment while in frictionless group, T-loops will be used for retraction. All the patients will receive two miniscrews , one on each side to achieve maximum anchorage during retraction.
The patients will be seen on a monthly basis for follow up visit for activation of the appliance to maintain constant force during the study. An impression will be taken for the patients every visit, poured into stone for fabrication of dental models. The models will be used to monitor the rate of retraction of anterior teeth.
Every patient will be asked for lateral cephalometric radiograph before and after complete retraction. After data collection, two assessors will carry on the measurements blindly and independently. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for en-masse retraction.
- Being tested
- Friction mechanics, Frictionless mechanics
- Keywords
- En-masse retraction , Class I bimaxillary protrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friction mechanicsDevice
Also called Nickel Titanium coil spring
Nickel Titanium will be extended from the hook between the lateral incisors and canines to the first molar bands, to allow frictional en-masse retraction of anterior segment.
Frictionless mechanicsDevice
Also called T-loops archwire
T-loops retraction arch will be placed distal to the upper canines and cinched distal to the first molar bands, to allow frictionless en-masse retraction of anterior segment.
| Study group | Role | What they receive |
|---|---|---|
| Friction mechanics | Active comparator | Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.
Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.
Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. Hook between upper laterals and canines will be fixed on the main archwire.
Nickel Titanium coil spring ( friction mechanics of retraction)will be used for maxillary en-masse retraction by extending the spring from the hook to the molar bands.
Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study. Receives: Device: Friction mechanics |
| Frictionless mechanics | Active comparator | Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.
Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.
Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. T-loops retraction arch ( frictionless mechanics of retraction)will be used for maxillary en-masse retraction. The wire will be cinched distal to the molar bands.
Re-activation of the retraction loops will be done in the follow up visits to maintain a constant force through the study Receives: Device: Frictionless mechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of retraction
months through clinical examination of the retracted anterior teeth
Measured: After complete retraction, average 9 months
Rate of retraction
millimeters through dental models taken for each patient monthly at the follow up visit
Measured: Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth
Patient Satisfaction
Questionnaire will be filled by every patient at the end of the study regarding his experience and acceptance to the treatment, scale from 0 to 5 .
Measured: After complete retraction , average 9 months
Secondary outcomes (3)
Change in incisors inclination
Degree and millimeter through lateral cephalometric analysis
Measured: After complete retraction, average 9 months
Change in soft tissue profile
Degree and millimeter through lateral cephalometric analysis
Measured: After complete retraction, average 9 months
molar anchorage loss
Degree and millimeter through lateral cephalometric analysis
Measured: After complete retraction, average 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startNov 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for En-masse Retraction , Class I Bimaxillary ProtrusionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Magdi Riad, Cairo University
- Investigators
- Fatma A. Abd El Sayed, Professor, Study chair, Cairo UniversityFady H. Fahim, lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261024
- Sponsor's protocol ID
- Evidence based dentistry EBD
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participant information won't be used outside the study except with written permission of the participant
Publications
Bills DA, Handelman CS, BeGole EA. Bimaxillary dentoalveolar protrusion: traits and orthodontic correction. Angle Orthod. 2005 May;75(3):333-9. doi: 10.1043/0003-3219(2005)75[333:BDPTAO]2.0.CO;2.
PubMed 15898369Park HS, Kwon TG. Sliding mechanics with microscrew implant anchorage. Angle Orthod. 2004 Oct;74(5):703-10. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
PubMed 15529508Park HS, Yoon DY, Park CS, Jeoung SH. Treatment effects and anchorage potential of sliding mechanics with titanium screws compared with the Tweed-Merrifield technique. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):593-600. doi: 10.1016/j.ajodo.2006.02.041.
PubMed 18405824Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.
PubMed 19061808Heo W, Nahm DS, Baek SH. En masse retraction and two-step retraction of maxillary anterior teeth in adult Class I women. A comparison of anchorage loss. Angle Orthod. 2007 Nov;77(6):973-8. doi: 10.2319/111706-464.1.
PubMed 18004930Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PubMed 23787192Felemban NH, Al-Sulaimani FF, Murshid ZA, Hassan AH. En masse retraction versus two-step retraction of anterior teeth in extraction treatment of bimaxillary protrusion. J Orthod Sci. 2013 Jan;2(1):28-37. doi: 10.4103/2278-0203.110330.
PubMed 24987640Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
PubMed 27275623Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.
PubMed 25309863Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.
PubMed 18617099Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.
PubMed 25657985Baxmann M, McDonald F, Bourauel C, Jager A. Expectations, acceptance, and preferences regarding microimplant treatment in orthodontic patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):250.e1-250.e10; discussion 250-1. doi: 10.1016/j.ajodo.2010.03.023.
PubMed 20816284Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.
PubMed 24696825Monga N, Kharbanda OP, Samrit V. Quantitative and qualitative assessment of anchorage loss during en-masse retraction with indirectly loaded miniscrews in patients with bimaxillary protrusion. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):274-82. doi: 10.1016/j.ajodo.2016.02.014.
PubMed 27476360Hedayati Z, Shomali M. Maxillary anterior en masse retraction using different antero-posterior position of mini screw: a 3D finite element study. Prog Orthod. 2016 Dec;17(1):31. doi: 10.1186/s40510-016-0143-z. Epub 2016 Oct 3.
PubMed 27667816
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients With Class I Bimaxillary Dentoalveolar Protrusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03261024
- Acronym / sponsor ID
- Evidence based dentistry EBD
- Keywords
- En-masse retraction , Class I bimaxillary protrusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 24 Aug 2017 (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.
This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.
Detailed description
Adult patients with Class I bimaxillary dentoalveolar protrusion will be recruited. All the patients need extraction of upper first premolars followed by anterior segment retraction and maximum anchorage.
The patients will be randomly allocated to one of two groups; either Friction or Frictionless group. In friction group, Nickel Titanium coil spring will be used for retraction of anterior segment while in frictionless group, T-loops will be used for retraction. All the patients will receive two miniscrews , one on each side to achieve maximum anchorage during retraction.
The patients will be seen on a monthly basis for follow up visit for activation of the appliance to maintain constant force during the study. An impression will be taken for the patients every visit, poured into stone for fabrication of dental models. The models will be used to monitor the rate of retraction of anterior teeth.
Every patient will be asked for lateral cephalometric radiograph before and after complete retraction. After data collection, two assessors will carry on the measurements blindly and independently. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for en-masse retraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Friction mechanics | Active comparator | Device: Friction mechanicsUpper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires. Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally. Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. Hook between upper laterals and canines will be fixed on the main archwire. Nickel Titanium coil spring ( friction mechanics of retraction)will be used for maxillary en-masse retraction by extending the spring from the hook to the molar bands. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study. |
| Frictionless mechanics | Active comparator | Device: Frictionless mechanicsUpper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires. Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally. Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. T-loops retraction arch ( frictionless mechanics of retraction)will be used for maxillary en-masse retraction. The wire will be cinched distal to the molar bands. Re-activation of the retraction loops will be done in the follow up visits to maintain a constant force through the study |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female adult patients with age range 18-30 yrs old.
- Class I bimaxillary dentoalveolar protrusion .
- Full permanent dentition.
- Good oral hygiene.
- Maximum anchorage is required.
Key exclusion criteria (5 listed)
- Systemic disease.
- Severe crowding.
- Extracted or missing upper permanent tooth/teeth (except for third molars).
- Any signs or symptoms or previous history of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
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 |
|---|---|---|
| Friction mechanicsAlso: Nickel Titanium coil springNickel Titanium will be extended from the hook between the lateral incisors and canines to the first molar bands, to allow frictional en-masse retraction of anterior segment. | Device | Friction mechanics |
| Frictionless mechanicsAlso: T-loops archwireT-loops retraction arch will be placed distal to the upper canines and cinched distal to the first molar bands, to allow frictionless en-masse retraction of anterior segment. | Device | Frictionless mechanics |
Primary outcome
Duration of retraction
Time frame: After complete retraction, average 9 months
months through clinical examination of the retracted anterior teeth
Rate of retraction
Time frame: Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth
millimeters through dental models taken for each patient monthly at the follow up visit
Patient Satisfaction
Time frame: After complete retraction , average 9 months
Questionnaire will be filled by every patient at the end of the study regarding his experience and acceptance to the treatment, scale from 0 to 5 .
3 secondary outcomes
Change in incisors inclination
Time frame: After complete retraction, average 9 months
Change in soft tissue profile
Time frame: After complete retraction, average 9 months
molar anchorage loss
Time frame: After complete retraction, average 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 15898369Bills DA, Handelman CS, BeGole EA. Bimaxillary dentoalveolar protrusion: traits and orthodontic correction. Angle Orthod. 2005 May;75(3):333-9. doi: 10.1043/0003-3219(2005)75[333:BDPTAO]2.0.CO;2.
- Background: PubMed 15529508Park HS, Kwon TG. Sliding mechanics with microscrew implant anchorage. Angle Orthod. 2004 Oct;74(5):703-10. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
- Background: PubMed 18405824Park HS, Yoon DY, Park CS, Jeoung SH. Treatment effects and anchorage potential of sliding mechanics with titanium screws compared with the Tweed-Merrifield technique. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):593-600. doi: 10.1016/j.ajodo.2006.02.041.
- Background: PubMed 19061808Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.
- Background: PubMed 18004930Heo W, Nahm DS, Baek SH. En masse retraction and two-step retraction of maxillary anterior teeth in adult Class I women. A comparison of anchorage loss. Angle Orthod. 2007 Nov;77(6):973-8. doi: 10.2319/111706-464.1.
- Background: PubMed 23787192Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- Background: PubMed 24987640Felemban NH, Al-Sulaimani FF, Murshid ZA, Hassan AH. En masse retraction versus two-step retraction of anterior teeth in extraction treatment of bimaxillary protrusion. J Orthod Sci. 2013 Jan;2(1):28-37. doi: 10.4103/2278-0203.110330.
- Background: PubMed 27275623Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
- Background: PubMed 25309863Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.
- Background: PubMed 18617099Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.
- Background: PubMed 25657985Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.
- Background: PubMed 20816284Baxmann M, McDonald F, Bourauel C, Jager A. Expectations, acceptance, and preferences regarding microimplant treatment in orthodontic patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):250.e1-250.e10; discussion 250-1. doi: 10.1016/j.ajodo.2010.03.023.
- Individual participant dataSharing planned: Undecided. Participant information won't be used outside the study except with written permission of the participant
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.
Fatma A. Abd El Sayed, Professor study chair
Cairo University
Fady H. Fahim, lecturer study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Friction mechanics and Frictionless mechanics in people with En-masse Retraction , Class I Bimaxillary Protrusion, run by Cairo University.
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 6 inclusion and 5 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Fady H. Fahim, Lecturer (+20-01006882595, fady.fahim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of retraction (time frame: After complete retraction, average 9 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 NCT03261024, which also lists 20 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 24 Aug 2017.