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

RecruitingNAAges 12 Years - 45 YearsAllShanghai Jiao Tong University School of Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Clear aligners with FM (Fluid Move) design
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Where

1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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