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Randomized Controlled Clinical Trial of Skeletal-Anchored vs Dental-Anchored Protraction Therapy for Class III Malocclusion Across Different Developmental Stages

Randomized Controlled Clinical Trial of Skeletal-Anchored vs Dental-Anchored Protraction Therapy for Class III Malocclusion Across Different Developmental Stages

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127044
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-07-01
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

Skeletal Class III Malocclusion

Interventions

Dental-anchored protraction therapy:A traditional Hyrax rapid maxillary expansion and protraction appliance was bonded to the right maxillary first premolar (UR6) and left maxillary first premolar (UL
Skeletal-anchored protraction therapy:A skeletal maxillary expansion and protraction device was bonded to the maxillary right first premolar (UR6) and the maxillary left first premolar (UL6). The inst

Sponsors

Nanjing Stomatological Hospital, Affiliated Hospital of Medical School, Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Age: Female: 7 years 180°, 22° < FMA < 30°, CVM stage II–IV. 4. No prior orthodontic treatment. 5. Informed consent signed by guardian.

Exclusion criteria

Exclusion criteria: 1. Genetic Syndromes: Achondroplasia, Down Syndrome, Cleidocranial Dysplasia, etc. 2. Congenital Disorders Affecting Craniofacial Development: Cleft Lip and Palate, Congenital Syphilis, Macroglossia, etc. 3. Congenital or Acquired Missing Teeth (Missing three or more teeth). 4. Impacted Anterior Teeth (Two or more impacted teeth). 5. History of Maxillofacial Trauma or Severe Infection. 6. Previous Orthodontic Treatment History. 7. Class I or Class II Malocclusion. 8. Systemic or Environmental Factors: Hormonal Imbalances or Disorders, Gigantism or Pituitary Adenoma; Systemic Diseases such as Rheumatoid Arthritis, Diabetes, Osteoporosis; Positive for Hepatitis B, HIV, or Syphilis. 9. Patients Unable to Cooperate with Treatment and Follow-Up.

Design outcomes

Primary

MeasureTime frame
A-Np (A to Nasion Perpendicular);

Secondary

MeasureTime frame
Craniofacial Skeletal Indicators;Dental Indicators;Compliance Rate and Adherence to Facemask Wear in Patients;

Countries

China

Contacts

Public ContactLi Huang

Nanjing Stomatological Hospital, Affiliated Hospital of Medical School, Nanjing University

lihuang76@nju.edu.cn+86 138 0515 8713

Outcome results

None listed

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