Bimaxillary ProtrusionNCT04921579
Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion
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
Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction … 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?
- 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
- 15 Dec 2019to 21 Jan 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults and adolescent patients ( both gender)
- Age range (14- 24)
- patient 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 required 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 Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion: A Randomized Clinical Trial
Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques
Read the detailed description
Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted 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 techniques results in a decreased treatment time is still up for debate.
- Conditions
- Bimaxillary Protrusion
- Being tested
- En masse retraction, Two-Step retraction
- Keywords
- En-masse retraction, two step retraction, friction, retraction time, Dental models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En masse retractionProcedure or surgery
Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.
Two-Step retractionProcedure or surgery
Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.
| Study group | Role | What they receive |
|---|---|---|
| En masse retraction | Experimental | six anterior teeth are retracted by en masse technique using a crimpable hook distal to 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 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.
Time to close extraction space
the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets
Measured: from pre to post retraction ( an average of 10 - 12 months)
Secondary outcomes (2)
Anchorage loss
Digitalized dental models taken before and after 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 10- 12 months)
pain of intervention
Each patient was informed to fill a questionnaire regarding treatment experience in Visual analogue scale scoring from (0 -10) 0 means no pain and 10 means severe pain
Measured: From pre to post retraction ( an average of 10 - 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Dec 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
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, Aya Ahmed El Ashwal, Future University in Egypt
- Investigators
- Yehia Mostafa, professor and chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921579
- Sponsor's protocol ID
- FUE.REC (23)/11-2019
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD sharing statement
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04921579
- Acronym / sponsor ID
- FUE.REC (23)/11-2019
- Conditions
- Bimaxillary Protrusion
- Keywords
- En-masse retraction, two step retraction, friction, retraction time, Dental models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 10 Jun 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.
Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques
Detailed description
Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted 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 techniques 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 | Experimental | Procedure: En masse retractionsix anterior teeth are retracted by en masse technique using a crimpable hook distal to 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 upper lateral incisor and a power chain. |
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 gender)
- Age range (14- 24)
- patient 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 required 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 |
|---|---|---|
| En masse retractionRetraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw. | 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 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw. | Procedure or surgery | two step retraction |
Primary outcome
Time to close extraction space
Time frame: from pre to post retraction ( an average of 10 - 12 months)
the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets
2 secondary outcomes
Anchorage loss
Time frame: From pre to post retraction ( an average of 10- 12 months)
pain of intervention
Time frame: From pre to post retraction ( an average of 10 - 12 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 10 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected IPD sharing statement
Related trials for Bimaxillary Protrusion
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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
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Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
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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 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 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 10 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?
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?
Time to close extraction space (time frame: from pre to post retraction ( an average of 10 - 12 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 10 Jun 2021.