Bimaxillary ProtrusionNCT04902430
Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion
A study testing Power chain and Crimpable hook for En-Masse Retraction and T- Loop in people with Bimaxillary Protrusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless… Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Protrusion
- What is being tested?
- Power chain and Crimpable hook for En-Masse Retraction and T- Loop
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Dec 2020to 12 Aug 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults and Adolescent patients (both genders)
- Age range (14-24)
- Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
- Patients with fully erupted permanent teeth (not necessarily including the third molar).
- Cases requiring maximum anchorage during retraction.
- Good general and oral health
Who cannot join
- Patients suffering from any systemic diseases interfering with tooth movement.
- Patients with extracted or missing permanent teeth. (except for third molars).
- Patients with badly decayed teeth.
- Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
- Patients with previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless Mechanics.
Read the detailed description
The en-masse technique can be done in one of two ways: through friction or frictionless mechanics. Both are viable options, but, ideally, we want to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these mechanics results in a decreased treatment time is still up for debate.
- Conditions
- Bimaxillary Protrusion
- Being tested
- Power chain and Crimpable hook for En-Masse Retraction, T- Loop
- Keywords
- En-masse Retraction, Friction, Fricitionless, Lateral Cephalometric, Rate, Dental Models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power chain and Crimpable hook for En-Masse RetractionProcedure or surgery
Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew
T- LoopProcedure or surgery
Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine
| Study group | Role | What they receive |
|---|---|---|
| En-Masse Retraction using sliding mechanics (Friction) | Experimental | 6 anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain Receives: Procedure: Power chain and Crimpable hook for En-Masse Retraction |
| En-Masse Retraction using segmental mechanics (Frictionless) | Experimental | 6 anterior teeth (en-Masse) retracted using a T- loop Receives: Procedure: T- Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retraction Rate
The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)
Measured: From pre to post retraction (an average of 6 - 8 months)
Secondary outcomes (4)
Anchorage Loss
Digitilized dental models taken before and after the completion of retraction will be measured by identifying landmarks and reference lines and planes (measured in mm)
Measured: From pre to post retraction (an average of 6 - 8 months)
Molar Rotation
Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)
Measured: From pre to post retraction (an average of 6 - 8 months)
Pain of intervention
Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10
Measured: From pre to post retraction/intervention (an average of 6 - 8 months)
Anterior teeth torque, extrusion/intrusion
The principle investigator will examine pre and post lateral cephalometric radiographs in relation to lines and reference planes (measurements in degrees and mm)
Measured: From pre to post retraction (an average of 6 - 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start29 Dec 2020
- Primary completion18 Jul 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProtrusionStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Alaa Shibl, Future University in Egypt
- Investigators
- Yehia Mostafa, Professor and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902430
- Sponsor's protocol ID
- FUE.REC (8)/6-2019
- Status last verified
- Dec 2022
- First submitted
- 12 May 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04902430
- Acronym / sponsor ID
- FUE.REC (8)/6-2019
- Conditions
- Bimaxillary Protrusion
- Keywords
- En-masse Retraction, Friction, Fricitionless, Lateral Cephalometric, Rate, Dental Models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 26 May 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.
There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless Mechanics.
Detailed description
The en-masse technique can be done in one of two ways: through friction or frictionless mechanics. Both are viable options, but, ideally, we want to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these mechanics results in a decreased treatment time is still up for debate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| En-Masse Retraction using sliding mechanics (Friction) | Experimental | Procedure: Power chain and Crimpable hook for En-Masse Retraction6 anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain |
| En-Masse Retraction using segmental mechanics (Frictionless) | Experimental | Procedure: T- Loop6 anterior teeth (en-Masse) retracted using a T- loop |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adults and Adolescent patients (both genders)
- Age range (14-24)
- Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
- Patients with fully erupted permanent teeth (not necessarily including the third molar).
- Cases requiring maximum anchorage during retraction.
Key exclusion criteria (5 listed)
- Patients suffering from any systemic diseases interfering with tooth movement.
- Patients with extracted or missing permanent teeth. (except for third molars).
- Patients with badly decayed teeth.
- Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…).
- Patients with 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 |
|---|---|---|
| Power chain and Crimpable hook for En-Masse RetractionRetraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew | Procedure or surgery | En-Masse Retraction using sliding mechanics (Friction) |
| T- LoopClosing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine | Procedure or surgery | En-Masse Retraction using segmental mechanics (Frictionless) |
Primary outcome
Retraction Rate
Time frame: From pre to post retraction (an average of 6 - 8 months)
The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)
4 secondary outcomes
Anchorage Loss
Time frame: From pre to post retraction (an average of 6 - 8 months)
Molar Rotation
Time frame: From pre to post retraction (an average of 6 - 8 months)
Pain of intervention
Time frame: From pre to post retraction/intervention (an average of 6 - 8 months)
Anterior teeth torque, extrusion/intrusion
Time frame: From pre to post retraction (an average of 6 - 8 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Bimaxillary Protrusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
Bimaxillary Proclination, Bimaxillary Protrusion
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Active, not recruiting
Effect of an AI Prediction Model of Facial Changes After Orthodontic Treatment of Patients With Bimaxillary Protrusion
Bimaxillary Protrusion
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.
Yehia Mostafa, Professor and Chairman study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power chain and Crimpable hook for En-Masse Retraction and T- Loop in people with Bimaxillary Protrusion, run by Future University in Egypt 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 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: finished, as of the sponsor's last update on 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retraction Rate (time frame: From pre to post retraction (an average of 6 - 8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2022.