Bimaxillary ProtrusionNCT04902456
Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion
A study testing Power chain and Crimpable hook fro 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 is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. 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 fro 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 29 Jan 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
- Orthodontic patients (both genders)
- Age range (14-24)
- Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
- Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
- Cases requiring maximum anchorage during anterior segment retraction.
- Cases with minimal crowding (2-3) mm
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 Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.
The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.
Read the detailed description
One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.
- Conditions
- Bimaxillary Protrusion
- Being tested
- Power chain and Crimpable hook fro En-masse Retraction, T-loop
- Keywords
- En-masse Retraction, Friction, Frictionless, CBCT, Anchorage, Anchorage loss, 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 fro En-masse RetractionProcedure or surgery
Retraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew
T-loopProcedure or surgery
closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.
| Study group | Role | What they receive |
|---|---|---|
| Power Chain and Crimpable hook for En-masse retraction | Experimental | Retraction will start on a 0.017x0.025" Stainless Steel wire using elastomeric chain ( force applied will be 212 g per side ) extending between the crimpable hooks and the miniscrew Receives: Procedure: Power chain and Crimpable hook fro En-masse Retraction |
| T-loop | Experimental | Closing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine. Receives: Procedure: T-loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anchorage loss
Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Secondary outcomes (6)
Retraction Rate
The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitally scanned dental models taken of the patients monthly ( measured in mm )
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Molar Rotation
Digitally scanned dental models that are taken before and after retraction will be assess the rotation of the maxillary first permanent molar in relation to a reference line ( measurement of the angles in degrees )
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Pain of Intervention
each patient will fill a questionnaire regarding his treatment experience in a Visual Analog Scale (VAS) scoring from 1-10 by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The question-naire will include several questions related to oral hygiene, pain and discomfort experienced throughout the trial.
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth extrusion/intrusion
The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in mm )
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth torque
The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )
Measured: from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth tip
The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )
Measured: from pre to post retraction/intervention ( 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 completion29 Jan 2022 (estimated)
- Study completion29 Jan 2022 (estimated)
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, Amr Mahmoud Attia, Future University in Egypt
- Investigators
- Yehia Mostafa, Professor and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902456
- Sponsor's protocol ID
- FUE.REC (13)/7-2019
- Status last verified
- Jun 2021
- First submitted
- 15 May 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04902456
- Acronym / sponsor ID
- FUE.REC (13)/7-2019
- Conditions
- Bimaxillary Protrusion
- Keywords
- En-masse Retraction, Friction, Frictionless, CBCT, Anchorage, Anchorage loss, Dental models
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 29 Jan 2022 (estimated)
- Study completion
- 29 Jan 2022 (estimated)
- 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 is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.
The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.
Detailed description
One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power Chain and Crimpable hook for En-masse retraction | Experimental | Procedure: Power chain and Crimpable hook fro En-masse RetractionRetraction will start on a 0.017x0.025" Stainless Steel wire using elastomeric chain ( force applied will be 212 g per side ) extending between the crimpable hooks and the miniscrew |
| T-loop | Experimental | Procedure: T-loopClosing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Orthodontic patients (both genders)
- Age range (14-24)
- Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
- Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
- Cases requiring maximum anchorage during anterior segment 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 fro En-masse RetractionRetraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew | Procedure or surgery | Power Chain and Crimpable hook for En-masse retraction |
| T-loopclosing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine. | Procedure or surgery | T-loop |
Primary outcome
Anchorage loss
Time frame: from pre to post retraction/intervention ( an average of 6-8 months )
Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )
6 secondary outcomes
Retraction Rate
Time frame: from pre to post retraction/intervention ( an average of 6-8 months )
Molar Rotation
Time frame: from pre to post retraction/intervention ( 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 extrusion/intrusion
Time frame: from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth torque
Time frame: from pre to post retraction/intervention ( an average of 6-8 months )
Anterior teeth tip
Time frame: from pre to post retraction/intervention ( an average of 6-8 months )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Yes
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Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
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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.
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 fro 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: status not confirmed, as of the sponsor's last update on 11 Jun 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?
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?
Anchorage loss (time frame: from pre to post retraction/intervention ( 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 11 Jun 2021.