MalocclusionNCT07896369
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
A study testing Clear aligners with FM (Fluid Move) design in people with Malocclusion, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Clear aligners with FM (Fluid Move) design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2026to 21 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 informed consent form
Who cannot join
- 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 glucocorticoids)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Bing Fang, +86-21-23271699, 2334944496@qq.com
About this study
Official title: Novel Low-Friction Molar Distalization (Fluid Move, FM) Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
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.
- Conditions
- Malocclusion
- Being tested
- Clear aligners with FM (Fluid Move) design
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear aligners with FM (Fluid Move) designDevice
Clear aligners with FM (Fluid Move) design
| Study group | Role | What they receive |
|---|---|---|
| FM (Fluid Move) Clear Aligner | Experimental | 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. Receives: Device: Clear aligners with FM (Fluid Move) design |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Time Frame: At T1 (about 3 months after treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Sep 2026
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Fang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Bing Fang, phd, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896369
- Sponsor's protocol ID
- ShanghaiJTU
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Low-Friction Molar Distalization (Fluid Move, FM) Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07896369
- Acronym / sponsor ID
- ShanghaiJTU
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FM (Fluid Move) Clear Aligner | Experimental | Device: Clear aligners with FM (Fluid Move) designAfter 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. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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 informed consent form
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Clear aligners with FM (Fluid Move) designClear aligners with FM (Fluid Move) design | Device | FM (Fluid Move) Clear Aligner |
Primary outcome
Time to Canine Distalization Completion (Months From Treatment Start to Canine Reaching Planned Position)
Time frame: From treatment start (T0) to canine distalization completion (T1), assessed up to 6 months
From treatment start (T0) to canine distalization completion (T1), assessed up to 6 months
1 secondary outcome
Molar Distalization Achievement Rate (Percent)
Time frame: Time Frame: At T1 (about 3 months after treatment start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Bing Fang, phd principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear aligners with FM (Fluid Move) design in people with Malocclusion, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 10 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingxuan Wang, phd (021-53315206, wangqx5022@sh9hospital.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Canine Distalization Completion (Months From Treatment Start to Canine Reaching Planned Position) (time frame: From treatment start (T0) to canine distalization completion (T1), assessed up to 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 27 Oct 2026.