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Exploratory research on the effectiveness of orthodontic treatment using a mouthpiece-type custom-made orthodontic device for malocclusion

Exploratory research on the effectiveness of orthodontic treatment using a mouthpiece-type custom-made orthodontic device for malocclusion - Effectiveness of mouthpiece type orthodontic appliance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049085
Enrollment
30
Registered
2022-09-30
Start date
2022-09-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malocculusion

Interventions

After closing the tooth extraction space using a multi-bracket device, fine adjustment is performed using a clear aligner orthodontic device.

Sponsors

Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 16 or over and under 40 at the time of obtaining consent 2. Patients who have extracted maxillary and mandibular premolars (regardless of the difference between the first and second premolars) and are undergoing orthodontic treatment with a multi-bracket appliance 3. Patients who can see a doctor once a month 4. Those who can obtain written consent from the person or a legally acceptable person regarding participation in this research

Exclusion criteria

Exclusion criteria: 1. Persons with a significant skeletal discrepancy 2. Subjects with congenital anomalies such as cleft lip and palate 3. Subjects with systemic diseases or medications that interfere with treatment 4. Persons with less than 24 teeth, excluding teeth extracted for convenience, wisdom teeth, and supernumerary teeth 5. Subjects who have ankylosis (osseous adhesion) due to trauma 6. Subjects with severe periodontal disease 7. Subjects who take painkillers frequently (more than once a day) 8. Others who are deemed inappropriate by the principal investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Evaluation of occlusal status: At the final stage of treatment, the occlusal status after dynamic treatment with a mouthpiece-type orthodontic appliance will be assessed using the American Board of Orthodontics (ABO) objective review system (OGS).

Secondary

MeasureTime frame
Usage time evaluation Assessment of pain during treatment X-ray evaluation Assess temporomandibular joint Assess temporomandibular joint Evaluation of periodontal condition Evaluation of caries Evaluation of duration of treatment

Countries

Japan

Contacts

Public ContactRyo Kunimatsu

Hiroshima University Orthodontics

ryoukunimatu@hiroshima-u.ac.jp0822575686

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026