Effect of Automated AI Designed Presurgical Plate Therapy on Cleft Size Reduction in Newborns With Cleft Lip and Palate : A Comparative Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Saveetha Medical College
RECRUITING
Chennai
GSR Hospital Hyderabad
RECRUITING
Hyderabad
Contact Information
Primary
Prasad Nalabothu, PhD
p.nalabothu@usb.ch
+41765014420
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 70
Treatments
Experimental: AI-Designed Passive Plate Therapy
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.
No_intervention: No Presurgical Therapy
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland
Collaborators: University of Basel

This content was sourced from clinicaltrials.gov