Bimaxillary ProtrusionNCT04878939
Evaluation of Incisors' Position Following Anterior Segment Retraction
A study testing Power chain used for anterior segment retraction and T-loop fabricated to perform anterior segment retraction in people with Bimaxillary Protrusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction. 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?
- Power chain used for anterior segment retraction and T-loop fabricated to perform anterior segment retraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Feb 2019to 13 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 patients (Age 13- 25 y)
- Class I molar relation (Angle's classification)
- Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
- full permanent dentition (except 3rd molars)
- Good general and oral health
Who cannot join
- Systemic disease or syndromes or on anti-inflammatory medication.
- Extracted or missing permanent teeth (other than 3rd molars)
- Badly decayed teeth (other than 1st premolars)
- Parafunctional habits
- History of previous orthodontics treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Incisors' Position Following Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
There's scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.
Read the detailed description
Thirty females with bimaxillary protrusion were randomly allocated into two groups. In one group, anterior segment retraction was commenced using an elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. In the other group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. Three-dimensional analysis of incisors' buccolingual (BL)- torque, mesiodistal (MD)- tip, vertical position changes and root resorption were assessed using cone beam computed tomography scans.
- Conditions
- Bimaxillary Protrusion
- Being tested
- Power chain used for anterior segment retraction, T-loop fabricated to perform anterior segment retraction
- Keywords
- friction, frictionless, CBCT, anterior segment retraction, T loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power chain used for anterior segment retractionOther
Elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor.
T-loop fabricated to perform anterior segment retractionOther
In the frictionless group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force.
| Study group | Role | What they receive |
|---|---|---|
| Anterior segment retraction using sliding mechanics (friction) | Experimental | Power chain Receives: Other: Power chain used for anterior segment retraction |
| Anterior segment retraction using segmental mechanics (frictionless) | Experimental | T-loop Receives: Other: T-loop fabricated to perform anterior segment retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque of the incisors
The change of the outer angle between long axis of each upper anterior tooth and palatal plane on CBCT pre and post retracation and the change in the outer angle between long axis of each lower anterior tooth and horizontal plane on CBCT pre and post retracation
Measured: through study completion (Pre/post retraction), an average of 6 months
Tip of the incisors
The change of the angle between the long axis of the incisors and mid-sagittal plane on CBCT pre and post retracation
Measured: through study completion (Pre/post retraction), an average of 6 months
Vertical changes of the incisors
The change of the linear distance between the centroid of each maxillary anterior tooth and palatal Plane on CBCT pre and post retracation and The change of the linear distance between centroid of each mandibular anterior tooth and horizontal Plane on CBCT pre and post retracation
Measured: through study completion (Pre/post retraction) , an average of 6 months
Secondary outcomes (1)
Root resorption of the anterior teeth
measuring the amount of resorption using CBCT in mm pre and post retraction
Measured: through study completion (Pre/post retraction), 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 posted10 May 2021
- Study start4 Feb 2019
- Primary completion1 Sep 2020
- Study completion13 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Dorra Bakhit, Future University in Egypt
- Investigators
- Yehia Mostafa, Professor and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878939
- Sponsor's protocol ID
- FUE.REC 11/10-2018
- Status last verified
- May 2021
- First submitted
- 25 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Bakhit DMI, Tawfik MGY, Dehis HM, Mostafa YA, El Sharaby FA. Position and root resorption of the incisors following anterior segment retraction using friction versus frictionless mechanics: A randomised controlled trial. J Orthod. 2025 Mar;52(1):12-21. doi: 10.1177/14653125241261402. Epub 2024 Jul 25.
PubMed 39049618
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Incisors' Position Following Anterior Segment Retraction Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04878939
- Acronym / sponsor ID
- FUE.REC 11/10-2018
- Conditions
- Bimaxillary Protrusion
- Keywords
- friction, frictionless, CBCT, anterior segment retraction, T loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 10 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 scarcity in literature concerning the issue of anterior segment retraction technique and its effect on anterior teeth position. Therefore, a randomized clinical trial has been chosen to investigate this issue, aiming to support clinicians with the best guidelines for anterior segment retraction.
Detailed description
Thirty females with bimaxillary protrusion were randomly allocated into two groups. In one group, anterior segment retraction was commenced using an elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. In the other group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. Three-dimensional analysis of incisors' buccolingual (BL)- torque, mesiodistal (MD)- tip, vertical position changes and root resorption were assessed using cone beam computed tomography scans.
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 sliding mechanics (friction) | Experimental | Other: Power chain used for anterior segment retractionPower chain |
| Anterior segment retraction using segmental mechanics (frictionless) | Experimental | Other: T-loop fabricated to perform anterior segment retractionT-loop |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female patients (Age 13- 25 y)
- Class I molar relation (Angle's classification)
- Bimaxillary protrusion requiring extraction of four first premolars and maximum anchorage.
- full permanent dentition (except 3rd molars)
- Good general and oral health
Key exclusion criteria (5 listed)
- Systemic disease or syndromes or on anti-inflammatory medication.
- Extracted or missing permanent teeth (other than 3rd molars)
- Badly decayed teeth (other than 1st premolars)
- Parafunctional habits
- History of previous orthodontics 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 used for anterior segment retractionElastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor. | Other | Anterior segment retraction using sliding mechanics (friction) |
| T-loop fabricated to perform anterior segment retractionIn the frictionless group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force. | Other | Anterior segment retraction using segmental mechanics (frictionless) |
Primary outcome
Torque of the incisors
Time frame: through study completion (Pre/post retraction), an average of 6 months
The change of the outer angle between long axis of each upper anterior tooth and palatal plane on CBCT pre and post retracation and the change in the outer angle between long axis of each lower anterior tooth and horizontal plane on CBCT pre and post retracation
Tip of the incisors
Time frame: through study completion (Pre/post retraction), an average of 6 months
The change of the angle between the long axis of the incisors and mid-sagittal plane on CBCT pre and post retracation
Vertical changes of the incisors
Time frame: through study completion (Pre/post retraction) , an average of 6 months
The change of the linear distance between the centroid of each maxillary anterior tooth and palatal Plane on CBCT pre and post retracation and The change of the linear distance between centroid of each mandibular anterior tooth and horizontal Plane on CBCT pre and post retracation
1 secondary outcome
Root resorption of the anterior teeth
Time frame: through study completion (Pre/post retraction), 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 10 May 2021.
- Derived from this study: PubMed 39049618Bakhit DMI, Tawfik MGY, Dehis HM, Mostafa YA, El Sharaby FA. Position and root resorption of the incisors following anterior segment retraction using friction versus frictionless mechanics: A randomised controlled trial. J Orthod. 2025 Mar;52(1):12-21. doi: 10.1177/14653125241261402. Epub 2024 Jul 25.
- Individual participant dataSharing planned: Yes. All collected IPD
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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 used for anterior segment retraction and T-loop fabricated to perform anterior segment 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 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 10 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?
Torque of the incisors (time frame: through study completion (Pre/post retraction), an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04878939, which also lists 1 linked publication.
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 May 2021.