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A diagnostic test for microform cleft lip based on ultrasound-assisted diagnosis

A diagnostic test for microform cleft lip based on ultrasound-assisted diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126276
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

microform cleft lip

Interventions

Gold Standard:Currently, the clinical diagnosis of microform cleft lip relies entirely on typical clinical manifestations, including discontinuity of the Cupid's bow on the affected side, elevation of
Index test:High-frequency ultrasound was used to examine the upper lip soft tissue in all subjects, recording the presence or absence of hypoechoic bands, their width, location, and dynamic changes wi

Sponsors

Plastic Surgery Hospital, Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inclusion Criteria for Case Group: (1) Clinically suspected microform cleft lip, presenting with one or more of the following external abnormalities: discontinuity of the Cupid's bow's peak, elevation of the Cupid's bow's peak, notching of the vermilion mucosa, grooving of the philtral skin, hyperpigmentation of the philtral skin, asymmetry of the bilateral nostrils, etc. (2) No age or gender restrictions. (3) No prior surgical treatment. (4) The patient or their legal guardian agrees to participate in the study and signs the informed consent form. 2. Inclusion Criteria for Control Group: (1) No congenital malformations of the lip and nose. (2) No prior history of surgery or trauma to the lip and nose. (3) No active infection in the lip and nose area. (4) The participant or their legal guardian agrees to participate in this study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Case Group: (1) Prior surgery or other treatment on the affected side. (2) Previous history of trauma to the lip and nose area. (3) Presence of other deformities affecting the morphology or function of the lip or nose, beyond the aforementioned abnormalities. (4) Active infection in the lip and nose area within the past 1 month, such as acne, herpes, folliculitis, eczema, etc., or a history of local dermatological treatment within the past 1 month. (5) Inability to cooperate in completing the upper lip ultrasound examination.

Design outcomes

Primary

MeasureTime frame
Width of the hypoechoic band on ultrasound;

Secondary

MeasureTime frame
Tissue layer of the hypoechoic band on ultrasound;

Countries

China

Contacts

Public ContactWeiyi Sun

Plastic Surgery Hospital, Academy of Medical Sciences and Peking Union Medical College

muqingswy@163.com+86 10 5396 8146

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026