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RecruitingNCT07896369Updated Oct 27, 2026

FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study

An interventional study of Clear aligners with FM (Fluid Move) design in Malocclusion, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
12 Years to 45 Years
Sex
All
01

Study summary

This trial tests whether a new method (FM) for moving back teeth can shorten clear-aligner treatment. All participants use FM, which moves the canine and first molar back together instead of one tooth at a time like the standard method. There is no comparison group; results will be compared with published studies and past records to plan a larger direct comparison. Participants wear FM aligners, have check-ups, scans, and photos at the start and at about 3 months, then check-ups every 1-3 months, for about 6 months total. People aged 12-45 with misaligned teeth needing back teeth moved back, healthy gums, and no need for tooth removal or jaw surgery can join.

Read the detailed description

The goal of this clinical trial is to learn if a new way to move the back teeth can shorten treatment time for people straightening their teeth with clear aligners. Clear aligners are clear, removable plastic trays that slowly move the teeth into a straighter position.

The main questions it aims to answer are:

  • How long does it take for the pointed teeth, called canines, to reach their planned position with the new method?
  • How closely do the back teeth, called molars, move to the planned position with the new method?

This study has one group. Everyone who joins will use the new method, called FM (Fluid Move). The FM method moves the canine and the first molar back at the same time, while the other teeth follow along. This is different from the standard method, called V-pattern, which moves the teeth back one at a time from the back of the mouth forward.

There is no comparison group in this study. Researchers will compare the results with results from published studies and with records from people treated in the past with the standard method. The results will help researchers plan a larger study that compares the two methods directly.

Participants will:

  • Wear clear aligners made with the FM design, following the same daily wear and care instructions as with standard clear aligner treatment
  • Come to the clinic for check-ups, teeth scans, and photos at the start of treatment and again at about 3 months
  • Come in for regular check-ups every 1 to 3 months during treatment
  • Take part in the study for about 6 months

People ages 12 to 45 can take part if they have crooked or misaligned teeth and need their back teeth moved back to make room for the front teeth. They must have healthy gums and must not need tooth removal or jaw surgery.

02

Conditions studied

  • Malocclusion

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 10 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 12 to 45 years (inclusive), either sex, with good oral hygiene and good compliance
  • Non-extraction orthodontic cases in which the treatment plan requires molar distalization to create space
  • Periodontally healthy: probing depth (PD) of 3 mm or less at all sites, and no active periodontal inflammation (no sites with bleeding on probing)
  • No history of orthodontic treatment
  • Participant and legal guardian voluntarily agree to take part and sign the form

Exclusion criteria

Exclusion Criteria:

  • Requires combined orthodontic and orthognathic surgery treatment
  • Missing teeth other than third molars in the maxillary or mandibular arch (first and second premolars must be present)
  • Diagnosed with severe dental crowding and assessed as requiring an extraction-based treatment plan
  • Active periodontal disease, uncontrolled periodontitis, or need for systematic periodontal treatment
  • Systemic disease affecting bone metabolism (for example, uncontrolled diabetes mellitus, osteoporosis, or rheumatoid arthritis)
  • Long-term use of medications that may affect tooth movement or bone metabolism (for example, bisphosphonates or )
  • Pregnancy, breastfeeding, or planned pregnancy during the study period
  • Obvious symptoms of temporomandibular disorder (pain, clicking, or limited mouth opening)
  • Known allergy to clear aligner material (for example, polyethylene terephthalate glycol-modified, PETG)
  • Expected to move away from the local area during the study period and unable to complete the required follow-up visits
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    FM (Fluid Move) Clear Aligner

    After providing informed consent, all enrolled participants will receive Angelalign clear aligners using FM shell structure technology, with the treatment plan designed to move teeth using the FM technique. All other aspects of the aligner material, aligner design, and wear requirements are the same as with conventional clear aligner treatment.

    Device: Clear aligners with FM (Fluid Move) design

Interventions

  • DeviceClear aligners with FM (Fluid Move) design

    Clear aligners with FM (Fluid Move) design

06

What researchers measure

Primary outcomes

  1. Time to Canine Distalization Completion (Months From Treatment Start to Canine Reaching Planned Position)

    From treatment start (T0) to canine distalization completion (T1), assessed up to 6 months

    Time frame: From treatment start (T0) to canine distalization completion (T1), assessed up to 6 months

Secondary outcomes

  1. Molar Distalization Achievement Rate (Percent)

    Achievement rate (%) = (a ÷ b) × 100, where: a = achieved tooth movement, calculated as the difference in displacement coordinates between the actual and planned tooth positions after digital model superimposition, using digital models obtained by intraoral optical scanning; and b = planned tooth movement, obtained from the treatment plan designed in the aligner design software.

    Time frame: Time Frame: At T1 (about 3 months after treatment start)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in publications will be available, including demographic and baseline characteristics, digital model measurements, time to canine distalization completion, and molar distalization achievement rate. Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication. Data will be shared with qualified researchers who provide a methodologically sound proposal, following approval by the Ethics Committee of Shanghai Ninth People's Hospital and execution of a data use agreement. Requests should be directed to the corresponding author. Because this study enrolls only 10 participants at a single center, individual-level data may be limited or released in summary form where necessary to protect participant privacy.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 7 months after the start.

Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 7 months is below that.

Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 27, 2026
StartActual
Sep 21, 2026
Primary completionEst.
Apr 21, 2027
CompletionEst.
Apr 21, 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896369
Responsible party
Bing Fang (professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Oct 27, 2026
Start date
Sep 21, 2026
Primary completion
Apr 21, 2027 (estimated)
Completion
Apr 21, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Qingxuan Wang, phd
Contact
wangqx5022@sh9hospital.org.cn
021-53315206
Bing Fang, phd
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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