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Research on the Application of 3D Printed Nasoalveolar Molding Appliances in the Sequential Treatment of Complete Cleft Lip and Palate

Research on the Application of 3D Printed Nasoalveolar Molding Appliances in the Sequential Treatment of Complete Cleft Lip and Palate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119973
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Cleft lip and palate

Interventions

3D Printing Group:Three-dimensional data collection, AI-assisted design, 3D printing of orthodontic appliances and wearing them, follow-up visits.
Traditional orthodontic appliance group:Traditional method involves taking the modulus, manually fabricating the orthodontic appliance and wearing it, followed by a follow-up visit.

Sponsors

Stomatological Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Weeks to 8 Weeks

Inclusion criteria

Inclusion criteria: Demographic characteristics: Newborns with unilateral complete cleft lip and palate who were born within 1-8 weeks and had a weight of at least 2.5 kilograms; Clinical features: Unilateral grade III cleft lip and palate, with the width of the lip fissure ranging from 5 to 12 millimeters; Family conditions: The guardian signs the informed consent form and commits to completing the follow-up (ensuring at least one follow-up visit per month, with the traditional group having one visit per week); Special consideration: Children from ethnic minorities such as the Miao people are recorded separately in a distinct category.

Exclusion criteria

Exclusion criteria: Absolute Prohibition: 1. Syndromic cleft lip and palate (such as the Pierre-Robin sequence syndrome) 2. Chromosome abnormalities such as trisomy 21 3. Severe congenital heart disease (cardiac function grade III-IV) 4. Had received orthodontic intervention in the past Relative taboos: 1. Premature infants (gestational age < 37 weeks) 2. Active oral infection

Design outcomes

Primary

MeasureTime frame
Width of alveolar cleft;Nasal symmetry index;

Countries

China

Contacts

Public ContactJiang Yunxian

Stomatological Hospital of Guizhou Medical University

738977959@qq.com+86 139 8519 8274

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026