Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate

NCT06970158 | Recruiting DMC

• 1 other identifier: placeholder unique ID
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to evaluate whether passive plate therapy using automated AI-designed devices can reduce cleft size in newborns with cleft lip and palate. The main questions it aims to answer are: Does AI-designed passive plate therapy reduce the cleft size between birth and primary surgery? (Primary aim) How does cleft size at the time of surgery compare between infants who received passive plate therapy and those who did not? (Secondary aim) Researchers will compare infants who received AI-designed passive plate therapy with those who received no presurgical therapy to determine whether the intervention leads to a greater reduction in cleft width. Participants will: Undergo intraoral scans at birth and again at the time of primary surgery, around 4 months of age. Receive either no presurgical intervention or be treated with AI-designed passive plates, depending on site-specific clinical practices

Conditions

Congenital Disorder; Cleft Lip Palate

Keywords

artificial intelligence; Cleft Lip Palate

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in Cleft Width from Birth to Primary Surgery

  Measured as the percentage change in anterior-posterior cleft width between the intraoral scan at birth and the scan at the time of primary surgery (\~4 months), in infants receiving AI-designed passive plate therapy.

  From birth to time of primary cleft surgery (approximately 4 months of age)

Secondary Outcomes (1)

• Cleft Width at Time of Primary Surgery

  At the time of primary cleft surgery (approximately 4 months of age)

Study Arms (2)

AI-Designed Passive Plate Therapy

EXPERIMENTAL

Infants in this group will receive passive plate therapy designed using an AI-assisted digital workflow. The plate is fitted shortly after birth and worn continuously until the time of primary surgical repair (around 4 months of age). Participants in this arm will undergo intraoral scans at birth and again at surgery.

Other: AI-Designed Passive Plate Therapy

No Presurgical Therapy

NO INTERVENTION

Infants in this group will not receive any presurgical orthopedic intervention. They will undergo a single intraoral scan at the time of primary surgical repair (around 4 months of age), which will be used for comparison with the intervention group.

Interventions

AI-Designed Passive Plate Therapy OTHER

A removable passive orthopedic plate designed using an AI-assisted digital workflow based on intraoral scan data. The design process is automated via a Blender-based software plugin that identifies anatomical landmarks and generates a custom-fit plate. The plate is 3D printed using biocompatible material and fitted shortly after birth. It is worn continuously until primary surgical repair, typically around 4 months of age. The intervention aims to reduce cleft width prior to surgery without requiring traditional impressions or extensive manual design effort.

Also known as: Automated Passive Plate

AI-Designed Passive Plate Therapy

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants diagnosed with unilateral cleft lip and palate Age at enrollment: within the first 14 days of life (for treatment group) Age at cleft surgery: approximately 4 months Medically stable and fit to undergo intraoral scanning and cleft surgery Parent or legal guardian has provided written informed consent

You may not qualify if:

• Syndromic cleft lip and palate or other craniofacial syndromes Bilateral cleft lip and palate Significant comorbidities affecting feeding, growth, or surgery (e.g., cardiac anomalies) Premature infants (\<37 weeks gestational age at birth) Infants who have already undergone any presurgical orthopedic intervention elsewhere Guardians/ Parents unwilling or unable to comply with follow-up or study procedures

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator

Study Sites (2)

Saveetha Medical College

Chennai, 602105, India

RECRUITING

GSR Hospital Hyderabad

Hyderabad, 500059, India

RECRUITING

Related Publications (5)

• Krozowski ZS, Murphy LC. Stabilisation of the cytoplasmic oestrogen receptor by molybdate. J Steroid Biochem. 1981 Apr;14(4):363-6. doi: 10.1016/0022-4731(81)90155-2. No abstract available.

  PMID: 7230798 BACKGROUND

• Benitez BK, Brudnicki A, Surowiec Z, Wieprzowski L, Rasadurai A, Nalabothu P, Lill Y, Mueller AA. Digital impressions from newborns to preschoolers with cleft lip and palate: A two-centers experience. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4233-4242. doi: 10.1016/j.bjps.2022.08.015. Epub 2022 Aug 22.

  PMID: 36154982 BACKGROUND

• Capizzi SA, Levy NT, Enriquez-Sarano M. Rheumatic fever revisited. Keep this diagnosis on your list of suspects. Postgrad Med. 1997 Dec;102(6):65-6, 71. doi: 10.3810/pgm.1997.12.383.

  PMID: 9406563 BACKGROUND

• Meyer S, Benitez BK, Thieringer FM, Mueller AA. Three-Dimensional Printable Open-Source Cleft Lip and Palate Impression Trays: A Single-Impression Workflow. Plast Reconstr Surg. 2024 Feb 1;153(2):462-465. doi: 10.1097/PRS.0000000000010684. Epub 2023 May 15.

  PMID: 37184464 BACKGROUND

• Rothman E. Biotechnology overview: where the industry is heading. Healthspan. 1987 Oct;4(9):19-24. No abstract available.

  PMID: 10284965 BACKGROUND

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andreas Mueller, PhD,MHBA

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Prasad Nalabothu, MDS PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prasad Nalabothu, PhD

CONTACT

+41765014420; p.nalabothu@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is implemented in this study. All parties, including care providers and outcome assessors, are aware of group assignments due to the nature of the intervention and clinical workflow.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: Participants will be assigned to one of two groups based on clinical site practices. The treatment group will receive AI-designed passive plate therapy from shortly after birth until primary surgery and will undergo intraoral scans at birth and at approximately 4 months of age. The comparison group will receive no presurgical intervention and will undergo a single intraoral scan at the time of primary surgery (around 4 months). This parallel design allows for evaluation of cleft size at surgery between treated and untreated groups.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2025
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Individual participant data will be made available beginning 6 months after publication of the primary study results and will remain available for a minimum of 3 years following that date. Requests for access can be submitted to the study team during this period.
• Access Criteria: Qualified researchers may request access to the de-identified individual participant data for the purpose of academic, non-commercial analyses related to cleft care, digital workflows, or AI-based interventions. Interested investigators must submit a written proposal detailing the research objectives and planned statistical analyses. Requests will be reviewed by the study's data access committee for scientific merit and ethical compliance. Approved researchers will be required to sign a data sharing agreement. Requests can be submitted via email to the principal investigator or designated institutional contact.

Locations

IN (2)