Maxillary hypoplasia in growing cleft lip and palate patients
Conditions
Interventions
Maxillary distraction with incomplete osteotomy:Maxillary incomplete osteotomy with rigid external distractor
maxillary trans-sutural distraction osteogenesis:maxillary trans-sutural distraction with rigid external distractor
Sponsors
Plastic Surgery Hospotal, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Age range 8-14 years old,male or female; 2. Birth diagnosis with cleft lip or cleft lip and palate, and has already been repaired; 3. Preoperative diagnosis with obvious maxillary hypoplasia, and imaging analysis showed that the horizontal advancement of maxilla was greater than or equal to 6mm; 4. Normal ability to communicate; 5. Preoperative examination was normal; 6. Patients or his guardian signed informed consent of this clinical study.
Exclusion criteria
Exclusion criteria: 1.Combined with other craniofacial anomalies; 2.Combined with palatal fistula; 3.previous orthodontic treatment, maxillary protraction,or other jaw correction surgery; 4.previous palatopharyngoplasty; 5.Preoperative examination results were abnormal; 6.Mental or hearing impairment affects experimental communication, and mental disorders cannot collaborate with doctors; 7.Active stage of infectious diseases; 8.Those who have previously participated in or are participating in relevant clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maxillary advancement in the horizontal direction;A-point advancement in the horizontal direction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial soft tissue 3D morphological changes;Speech effect evaluation; | — |
Countries
China
Contacts
Public ContactTong Haizhou
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed