comparison of two different technique 3D printed and conventional nasoalveolar molding plates in newborns with gap in the lip region and hole in the roof(palate) of the mouth

Comparative evaluation of Presurgical Nasoalveolar Molding using digitally designed & 3D printed NAM appliance with modified Graysons NAM appliance in unilateral cleft lip and palate infants- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053938

Enrollment

Registered

2023-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: Q371- Cleft hard palate with unilateralcleft lip

Interventions

Intervention1: 3d Printed Nasoalveolar Molding appliances: 3 months of intervention period until desirable closure of cleft achieved before chelioplasty. To evaluate the reduction of cleft width,chan

Eligibility

Inclusion criteria

Inclusion criteria: Infants with unilateral cleft lip and palate Age range of the infant- Over 10 days post parturition until 1 month both sexes

Exclusion criteria

Exclusion criteria: Infants who require hospitalization and medical care due to systemic illness Infants with associated syndromes

Design outcomes

Primary

Measure	Time frame
To compare the effectiveness of 3D printed nasoalveolar molding(NAM) appliance with conventional NAM appliance with regards to treatment outcomes & to evaluate the dentoalveolar changes occurring in the maxillary arch presurgically in unilateral cleft lip & palate before and after the Nasoalveolar molding therapy Timepoint: 15days,30days,45days,60days,75days,90days	—

Secondary

Measure	Time frame
To compare the effectiveness of intervention of 3D nasal hook in 3D printed nasoalveolar molding appliance with conventional appliances therapy in unilateral cleft lip & palate infantsTimepoint: 15days,30days,45days,60days,75days,90days	—

Countries

India

Contacts

Public ContactDr Prashanth S

JSS Dental College and Hospital,JSS Academy of Higher Education and Research

dr.prashanths@jssuni.edu.in9341816701

Outcome results

None listed

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