AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Egypt1 site
  • Egypt

    Al Mansurah, +20

Other trials in Egypt

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.

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 groups in NCT05542745
Study groupRoleWhat they receive
palatal retractorActive comparatorpalatal retraction
Receives: Device: palatal and buccal retraction
buccal retractorActive comparatorbuccal retraction
Receives: Device: palatal and buccal retraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 Sep 2022
  2. Study start20 Feb 2020
  3. Primary completion26 Mar 2021
  4. Study completion14 Jul 2022

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in