Bimaxillary ProtrusionNCT05150665
Evaluation of Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction
A study testing En-masse retraction and Two step Retraction 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 mini-esthetics specially maxillary gingival display changes following en-masse retraction and two-step retraction. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which technique of retraction will result in better esthetics upon… Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Protrusion
- What is being tested?
- En-masse retraction and Two step Retraction
- 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 Oct 2020to 28 Dec 2021
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults and Adolescent patients (both genders)
- Age range (16-24)
- 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 neural disorders or systemic diseases interfering with tooth movement.
- Patients with soft tissue problems such as cleft-palate patients
- 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 Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction in Maxillary Protrusion Cases: A Randomized Clinical Trial
There's a scarcity in literature concerning mini-esthetics specially maxillary gingival display changes following en-masse retraction and two-step retraction. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which technique of retraction will result in better esthetics upon smiling following en-masse retraction or two step retraction mechanics.
Read the detailed description
This study will be conducted in order to evaluate which technique of retraction will provide better outcome regarding mini and macro esthetics. In terms of mini esthetics, posed smiles will be analyzed to evaluate maxillary gingival display, as well as the analysis of smile arc, buccal corridor, inter-labial gap. In terms of macro esthetics, frontal and profile poses will be assessed to evaluate the nasolabial angle, mentolabial angle and upper and lower lip protrusion/ E- plane.
- Conditions
- Bimaxillary Protrusion
- Being tested
- En-masse retraction, Two step Retraction
- Keywords
- Mini-esthetics, Macro-esthetics, En-masse Retraction, Two step retraction, Extra-oral photographs, Adobe photoshop CC 2017 software, Lateral Cephalometric Radiographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En-masse retractionProcedure or surgery
Power chain and Crimpable hook for En-Masse Retraction Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 200 g per side) extending between the crimpable hooks and the miniscrew
Two step RetractionProcedure or surgery
Retraction of canine started on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 150 g per side)followed by anterior teeth retraction on 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 160 g per side) extending between the crimpable hooks and the mini-screw.
| Study group | Role | What they receive |
|---|---|---|
| En-Masse Retraction | Experimental | Six anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain Receives: Procedure: En-masse retraction |
| two step retraction | Experimental | Six anterior teeth are retracted by two step technique by canine retraction followed by four anterior teeth retraction using a crimpable hook distal to the upper lateral incisor and a power chain Receives: Procedure: Two step Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-esthetics including
Evaluation of (maxillary gingival display, Smile arc, buccal corridor) from social smile photograph Evaluation of (inter-labial gap) from At Rest photograph All primary outcome characteristics will be measured before and after retraction (measured Linear/ horizontal/ vertical in millimeters) by Adobe Photoshop CC 2017 software.
Measured: From pre to post retraction (an average of 6 - 8 months)]
Secondary outcomes (1)
Macro-esthetics evaluation of profile photograph including
- Nasolabial angle. 2. Mentolabial angle. 3. Incisors Inclination (Angular measurement in degrees). 4. Upper lip protrusion/ E- plane. 5. Lower lip protrusion/ E- plane. (Linear measurement in millimeters.) Cephalometric radiographs and Adobe Photoshop CC 2017 software
Measured: upto 6 months from the start of orthodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start29 Oct 2020
- Primary completion28 Dec 2021 (estimated)
- Study completion28 Dec 2021 (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, Sara Usama Saeed Imam, Future University in Egypt
- Investigators
- Yehya mostafa, Professor and chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150665
- Sponsor's protocol ID
- FUE.REC(26)/12-2019
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction in Maxillary Protrusion Cases: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05150665
- Acronym / sponsor ID
- FUE.REC(26)/12-2019
- Conditions
- Bimaxillary Protrusion
- Keywords
- Mini-esthetics, Macro-esthetics, En-masse Retraction, Two step retraction, Extra-oral photographs, Adobe photoshop CC 2017 software, Lateral Cephalometric Radiographs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 28 Dec 2021 (estimated)
- First posted
- 9 Dec 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 mini-esthetics specially maxillary gingival display changes following en-masse retraction and two-step retraction. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which technique of retraction will result in better esthetics upon smiling following en-masse retraction or two step retraction mechanics.
Detailed description
This study will be conducted in order to evaluate which technique of retraction will provide better outcome regarding mini and macro esthetics. In terms of mini esthetics, posed smiles will be analyzed to evaluate maxillary gingival display, as well as the analysis of smile arc, buccal corridor, inter-labial gap. In terms of macro esthetics, frontal and profile poses will be assessed to evaluate the nasolabial angle, mentolabial angle and upper and lower lip protrusion/ E- plane.
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 | Experimental | Procedure: En-masse retractionSix anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain |
| two step retraction | Experimental | Procedure: Two step RetractionSix anterior teeth are retracted by two step technique by canine retraction followed by four anterior teeth retraction using a crimpable hook distal to the upper lateral incisor and a power chain |
Who may qualify
- Ages
- 16 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 (16-24)
- 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 (6 listed)
- Patients suffering from any neural disorders or systemic diseases interfering with tooth movement.
- Patients with soft tissue problems such as cleft-palate patients
- 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....).
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 |
|---|---|---|
| En-masse retractionPower chain and Crimpable hook for En-Masse Retraction Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 200 g per side) extending between the crimpable hooks and the miniscrew | Procedure or surgery | En-Masse Retraction |
| Two step RetractionRetraction of canine started on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 150 g per side)followed by anterior teeth retraction on 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 160 g per side) extending between the crimpable hooks and the mini-screw. | Procedure or surgery | two step retraction |
Primary outcome
Mini-esthetics including
Time frame: From pre to post retraction (an average of 6 - 8 months)]
Evaluation of (maxillary gingival display, Smile arc, buccal corridor) from social smile photograph Evaluation of (inter-labial gap) from At Rest photograph All primary outcome characteristics will be measured before and after retraction (measured Linear/ horizontal/ vertical in millimeters) by Adobe Photoshop CC 2017 software.
1 secondary outcome
Macro-esthetics evaluation of profile photograph including
Time frame: upto 6 months from the start of orthodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
Yehya 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 En-masse retraction and Two step Retraction 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 6 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 9 Dec 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?
Mini-esthetics including (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 9 Dec 2021.