Bimaxillary ProtrusionNCT04892056
Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics
A study testing Friction Mechanics and Frictionless Mechanics in people with Bimaxillary Protrusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done. Read more about this study
- Who is it for?
- Ages 13 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bimaxillary Protrusion
- What is being tested?
- Friction Mechanics and Frictionless Mechanics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 15 Dec 2020
- 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 13 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female Subjects.
- Age 13-25 y of age.
- Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
- Fully erupted permanent dentition without crowding.
- Good oral and general health.
Who cannot join
- Systemic Diseases or syndromes or on anti-inflammatory medication.
- Extracted or missing permanent teeth.
- History of previous Orthodontic Treatment.
- Parafunctional Habits.
- Badly decayed teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Rate of Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.
Read the detailed description
Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.
- Conditions
- Bimaxillary Protrusion
- Being tested
- Friction Mechanics, Frictionless Mechanics
- Keywords
- T loops, Friction, Frictionless, power chains, digital models, anterior segment retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friction MechanicsOther
Also called sliding mechanics
anterior segment retraction using elastomeric power chains
Frictionless MechanicsOther
Also called segmented mechanics
anterior segment retraction using closing loops
| Study group | Role | What they receive |
|---|---|---|
| Anterior Segment Retraction using Friction mechanics by elastomeric power chains | Experimental | Elastomeric power chains extending from 8mm crimpable hooks, distal to the lateral incisors, on 0.017"x0.025" Stainless Steel WIres, to the mini-screws. The power chains delivered 160g of force per side. Receives: Other: Friction Mechanics |
| Anterior Segment Retraction using Frictionless mechanics by T-loops | Experimental | T shaped closing loops were fabricated on 0.017"x0.025" Titanium- Molybdenum wires (TMA) were used to deliver 160g of force per side by 4mm distal activations. Receives: Other: Frictionless Mechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anterior Segment Retraction
The rate of anterior segment retraction per month was measured on monthly digital models.
Measured: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Secondary outcomes (2)
Anchorage Loss
Mesial movement of the first primary molar was evaluated on the digital models
Measured: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Pain experienced after each activation of the two mechanics
Patients were asked to complete Visual Analogue Scales of the degree of pain after every intervention. The scale values between 0 to 10, with 0 being no pain experienced by the patient and 10 being the highest level of pain experienced.
Measured: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Feb 2019
- Primary completion10 Jun 2020
- Study completion15 Dec 2020
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
- Other
- 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, Monica Guirguis Youssif Tawfik, Future University in Egypt
- Investigators
- Yehia Mostafa, Chairman, Study chair, Future Univeristy in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892056
- Sponsor's protocol ID
- FUE.REC 9/10-2018
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rate of Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04892056
- Acronym / sponsor ID
- FUE.REC 9/10-2018
- Conditions
- Bimaxillary Protrusion
- Keywords
- T loops, Friction, Frictionless, power chains, digital models, anterior segment retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 19 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.
The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated comparing the friction and friction-less mechanics. since, there has been a lack of clear cut guidelines for clinicians for the optimum method for retraction, this randomized clinical trial was done.
Detailed description
Thirty bi-maxillary protrusion female patients were randomly allocated into either intervention groups. In the Friction group, retraction was accomplished using elastomeric power chains extending from crimpable hooks distal to the lateral incisors, on 0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum wires. Retraction force was set to 160g per side in both intervention groups. Activation was done every four weeks. Rate of anterior segment retraction was evaluated via digital models.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Segment Retraction using Friction mechanics by elastomeric power chains | Experimental | Other: Friction MechanicsElastomeric power chains extending from 8mm crimpable hooks, distal to the lateral incisors, on 0.017"x0.025" Stainless Steel WIres, to the mini-screws. The power chains delivered 160g of force per side. |
| Anterior Segment Retraction using Frictionless mechanics by T-loops | Experimental | Other: Frictionless MechanicsT shaped closing loops were fabricated on 0.017"x0.025" Titanium- Molybdenum wires (TMA) were used to deliver 160g of force per side by 4mm distal activations. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female Subjects.
- Age 13-25 y of age.
- Skeletal Angle Class I malocclusion with Bimaxillary dentoalveolar protrusion in need of four 1st premolar extractions with maximum anchorage.
- Fully erupted permanent dentition without crowding.
- Good oral and general health.
Key exclusion criteria (5 listed)
- Systemic Diseases or syndromes or on anti-inflammatory medication.
- Extracted or missing permanent teeth.
- History of previous Orthodontic Treatment.
- Parafunctional Habits.
- Badly decayed teeth.
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: sliding mechanicsanterior segment retraction using elastomeric power chains | Other | Anterior Segment Retraction using Friction mechanics by elastomeric power chains |
| Frictionless MechanicsAlso: segmented mechanicsanterior segment retraction using closing loops | Other | Anterior Segment Retraction using Frictionless mechanics by T-loops |
Primary outcome
Rate of Anterior Segment Retraction
Time frame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
The rate of anterior segment retraction per month was measured on monthly digital models.
2 secondary outcomes
Anchorage Loss
Time frame: The start of anterior segment retraction up to complete space closure, an average of 6 months.
Pain experienced after each activation of the two mechanics
Time frame: The start of anterior segment retraction up to complete space closure, an average of 6 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 19 May 2021.
- Individual participant dataSharing planned: Yes. All collected IPD shared.
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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, Chairman study chair
Future Univeristy 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 Friction Mechanics and Frictionless Mechanics 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 5 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 19 May 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?
Rate of Anterior Segment Retraction (time frame: The start of anterior segment retraction up to complete space closure, an average of 6 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 19 May 2021.