Class II Division 1 MalocclusionNCT05542745
Measuring Rate of Anteriors Retraction With Two Different Techniques
A study testing palatal and buccal retraction in people with Class II Division 1 Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
Few studies had investigated the effectiveness of segmental retraction. As a result of that, this study was concerned about comparing retraction rate of maxillary incisors between buccal and palatal mini-implant supported retraction groups in Class II division 1 non growing patients for 3 months interval. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- palatal and buccal retraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 14 Jul 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Class II division 1 malocclusion with no or mild crowding 2. Age ranging from 14 to 18 years.
Who cannot join
- No previous orthodontic therapy of any type prior to this treatment No systematic disease Good oral hygiene and no periodontal problems No abnormal oral habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rate of Upper Incisors Retraction in Class II Division 1 Patients Managed With Palatal Versus Buccal Miniscrew Supported Segmental Orthodontics: Randomized Clinical Trial
Few studies had investigated the effectiveness of segmental retraction. As a result of that, this study was concerned about comparing retraction rate of maxillary incisors between buccal and palatal mini-implant supported retraction groups in Class II division 1 non growing patients for 3 months interval.
Read the detailed description
Almost all patients their primary concern is the total duration of orthodontic treatment. So, the need to choose the best mean to fasten the tooth movement rate with least drawbacks increased . Many new bracket techniques and prescriptions have been evolved since straight wire technique of Andrew's was advanced. All of these progressions are to make a system of force which can decrease the overall management time.
Commonly, extractions and maximum anchorage are planned to manage different malocclusions in orthodontic treatment especially in protrusion cases. Space closure is an important step following extraction. So, space closure strategy must be individually adjusted depending on diagnosis and plan of treatment. Nowadays several options are used to fasten movement of tooth. New techniques like implants assisted retraction, lessen the time of retraction and accordingly the total time of treatment.
Control of anchorage is an important factor in orthodontic therapy success. Mini-implants are method of absolute anchorage control .These systems improves the anchorage, but still have some drawbacks like surgical intervention and patient compliance. However, their usage becomes a necessity and unavoidable in many cases. Buccal TADs could provide superior results when retracting anterior teeth in patients with moderate to severe protrusion.
Lingual orthodontics introduction created novel horizons in orthodontic therapy. Labial orthodontics varied differentially in biomechanics from the lingual one. Because of its positional biomechanical advantage, lingual orthodontics offers higher anchorage and higher rate of retraction; as the lingual appliance force applied near to the tooth center of resistance than in the labial ones.
Control of torque is not simple in traditional lingual orthodontics. The C-lingual retractor is great for lip protrusion cases that need maximum anchorage.Bonding the C-retractor to the palatal aspect of the upper anteriors, adding maximum esthetics. Mini-implants are inserted palataly and decrease the need of posterior anchorage for retraction of upper anterior teeth. This is named lingual biocreative therapy. Palatal TSADs can provide wide range of force application level, due to the depth of palatal vault. By the adjustment of the lever arm length and position of miniscrews, the desired line of action of the retraction force with respect to the center of resistance of the anterior segment can be achieved.Segmental retraction is an approach using palatal TSADs as direct anchorage. The anterior teeth were splinted on the lingual side, and they are retracted to the palatal TSADs using elastomers or NiTi coil springs through a lever connected to the anterior segment.
It is critical to locate and manage the center of resistance relative to the force vector of retraction. By using this, the orthodontist can estimate the power arm length which would provide controlled tipping, or bodily movement of the anterior area.
There is a lack of studies evaluating the rate of movement of incisors in cases treated with palatal retraction so new investigations are needed in this area. Because of the biomechanical differences between buccal and palatal retraction, this study targeted the comparison of the rate of retraction in upper anteriors following leveling and alignment in class II division 1 patients managed by either method.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- palatal and buccal retraction
- Keywords
- Orthodontics, incisors retraction, mini-implants, direct- anchorage.
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatal and buccal retractionDevice
comparison
| Study group | Role | What they receive |
|---|---|---|
| palatal retractor | Active comparator | palatal retraction Receives: Device: palatal and buccal retraction |
| buccal retractor | Active comparator | buccal retraction Receives: Device: palatal and buccal retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of retraction
distance travelled at specific time interval
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start20 Feb 2020
- Primary completion26 Mar 2021
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ElBialy, Principal investigator, Faculty of Dentistry Mansoura Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542745
- Sponsor's protocol ID
- M10061119
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Upper Incisors Retraction in Class II Division 1 Patients Managed With Palatal Versus Buccal Miniscrew Supported Segmental Orthodontics: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05542745
- Acronym / sponsor ID
- M10061119
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Orthodontics, incisors retraction, mini-implants, direct- anchorage.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 15 Sep 2022 (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.
Few studies had investigated the effectiveness of segmental retraction. As a result of that, this study was concerned about comparing retraction rate of maxillary incisors between buccal and palatal mini-implant supported retraction groups in Class II division 1 non growing patients for 3 months interval.
Detailed description
Almost all patients their primary concern is the total duration of orthodontic treatment. So, the need to choose the best mean to fasten the tooth movement rate with least drawbacks increased . Many new bracket techniques and prescriptions have been evolved since straight wire technique of Andrew's was advanced. All of these progressions are to make a system of force which can decrease the overall management time.
Commonly, extractions and maximum anchorage are planned to manage different malocclusions in orthodontic treatment especially in protrusion cases. Space closure is an important step following extraction. So, space closure strategy must be individually adjusted depending on diagnosis and plan of treatment. Nowadays several options are used to fasten movement of tooth. New techniques like implants assisted retraction, lessen the time of retraction and accordingly the total time of treatment.
Control of anchorage is an important factor in orthodontic therapy success. Mini-implants are method of absolute anchorage control .These systems improves the anchorage, but still have some drawbacks like surgical intervention and patient compliance. However, their usage becomes a necessity and unavoidable in many cases. Buccal TADs could provide superior results when retracting anterior teeth in patients with moderate to severe protrusion.
Lingual orthodontics introduction created novel horizons in orthodontic therapy. Labial orthodontics varied differentially in biomechanics from the lingual one. Because of its positional biomechanical advantage, lingual orthodontics offers higher anchorage and higher rate of retraction; as the lingual appliance force applied near to the tooth center of resistance than in the labial ones.
Control of torque is not simple in traditional lingual orthodontics. The C-lingual retractor is great for lip protrusion cases that need maximum anchorage.Bonding the C-retractor to the palatal aspect of the upper anteriors, adding maximum esthetics. Mini-implants are inserted palataly and decrease the need of posterior anchorage for retraction of upper anterior teeth. This is named lingual biocreative therapy. Palatal TSADs can provide wide range of force application level, due to the depth of palatal vault. By the adjustment of the lever arm length and position of miniscrews, the desired line of action of the retraction force with respect to the center of resistance of the anterior segment can be achieved.Segmental retraction is an approach using palatal TSADs as direct anchorage. The anterior teeth were splinted on the lingual side, and they are retracted to the palatal TSADs using elastomers or NiTi coil springs through a lever connected to the anterior segment.
It is critical to locate and manage the center of resistance relative to the force vector of retraction. By using this, the orthodontist can estimate the power arm length which would provide controlled tipping, or bodily movement of the anterior area.
There is a lack of studies evaluating the rate of movement of incisors in cases treated with palatal retraction so new investigations are needed in this area. Because of the biomechanical differences between buccal and palatal retraction, this study targeted the comparison of the rate of retraction in upper anteriors following leveling and alignment in class II division 1 patients managed by either method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palatal retractor | Active comparator | Device: palatal and buccal retractionpalatal retraction |
| buccal retractor | Active comparator | Device: palatal and buccal retractionbuccal retraction |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Class II division 1 malocclusion with no or mild crowding 2. Age ranging from 14 to 18 years.
Key exclusion criteria (1 listed)
- No previous orthodontic therapy of any type prior to this treatment No systematic disease Good oral hygiene and no periodontal problems No abnormal oral habits
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 |
|---|---|---|
| palatal and buccal retractioncomparison | Device | buccal retractor, palatal retractor |
Primary outcome
rate of retraction
Time frame: 3 months
distance travelled at specific time interval
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 15 Sep 2022.
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EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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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.
ElBialy principal investigator
Faculty of Dentistry Mansoura Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palatal and buccal retraction in people with Class II Division 1 Malocclusion, run by Mansoura University 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 1 inclusion and 1 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 15 Sep 2022. 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 retraction (time frame: 3 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 15 Sep 2022.