FM Move: A New Method for Moving Back Teeth During Clear Aligner Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial uses a one-arm design to evaluate a new FM (Fluid Move) design for clear aligners in patients with malocclusion requiring molar distalization. Participants wear FM aligners and have baseline, around 3-month, and ongoing follow-up visits every 1–3 months for up to about 6 months, with scans and photos to document progress. The study compares outcomes to published data and past records rather than using a concurrent control group, to inform planning for a larger direct-comparison study. Eligible participants are aged 12–45 with non-extraction molar distalization needs, good oral health, and no active periodontal disease. No surgical or extraction plans are allowed in the inclusion criteria, and certain dental conditions exclude participation.

Why it matters

Who can join: the full rules

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 informed consent form

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 glucocorticoids)
* 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

Where it's running

• Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Bing Fang, phd — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Qingxuan Wang, phd
• Email: wangqx5022@sh9hospital.org.cn
• Phone: 021-53315206

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.