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Recruiting Not applicable

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

NCT07896369 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-21
Last updated
2026-10-27

Condition(s) studied

Malocclusion

Investigational drug(s) / intervention(s)

Clear aligners with FM (Fluid Move) design

Clear aligners with FM (Fluid Move) design: Clear aligners with FM (Fluid Move) design

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07896369 on ClinicalTrials.gov ↗ ← All trials in China