NCT07896369 FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
| NCT ID | NCT07896369 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Malocclusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-09-21 |
| Primary Completion | 2027-04-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-09-21 with a primary completion date of 2027-04-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Bing Fang, phd
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT07896369 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 45 Years, studying Malocclusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07896369 currently recruiting?
Yes, NCT07896369 is actively recruiting participants. Contact the research team at wangqx5022@sh9hospital.org.cn for enrollment information.
Where is the NCT07896369 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07896369 clinical trial?
NCT07896369 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Bing Fang, phd at Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 10 participants.