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Comparison of treatment outcomes with Rhinoplastic Appliance System with and without the use of intraoral plate in patients with Unilateral Cleft Lip and Palate

Comparative Assessment of Rhinoplastic Appliance System with and without the Integration of Intraoral Appliance in Unilateral Cleft Lip and Palate - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087973
Enrollment
36
Registered
2025-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: Q385- Congenital malformations of palate, not elsewhere classified

Interventions

Intervention1: Nasoalveolar moulding in Unilateral Cleft Lip and Palate: Nasoalveolar Moulding with Rhinoplastic Appliance System with intraoral plate Control Intervention1: Nasoalveolar moulding with

Sponsors

Simran Shakya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Non Syndromic Unilateral Cleft Lip And Palate Born at full term 0 days 3 months infants for PSIO 3-6 months infants for post surgery follow up

Exclusion criteria

Exclusion criteria: Syndromic cleft lip and palate Infant with systemic diseases Infants with Simonart s Band Parents/ guardians not providing assent

Design outcomes

Primary

MeasureTime frame
Comparison of intra group arch dimension and facial esthetics comparison of inter group evaluation of arch dimension and facial esthetics Timepoint: T0 before Nasoalveolar moulding at baseline T1 after Nasoalveolar moulding at 4 months

Secondary

MeasureTime frame
Comparison of arch dimension and facial esthetics after primary lip surgeryTimepoint: T2 6 months after primary lip surgery

Countries

India

Contacts

Public ContactDr Dhruv Ahuja

Manav Rachna Dental College

drpuneetbatra@gmail.com9810335961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026