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NCT04422847: 3D obturator
Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
NA trial testing 3D obturator in Cleft Lip and Palate in 120 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Brno University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 120 |
| Start date | 1 August 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- 3D obturator
Conditions studied
- Cleft Lip and Palate — all drugs for Cleft Lip and Palate →
Sponsor
Brno University Hospital
Who can join
Under 2, any sex, with Cleft Lip and Palate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood. At the University Hospital Brno, the treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the University Hospital Brno. The main specialties that form the basis of CC include plastic surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are divided into 2 main groups based on the embryological causes of clefts: 1/ patients with cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to the age of the patients, but mainly to the cleft itself. Anesthesiology management, and especially intubation of these patients, are often difficult due to the nature of the defect with high incidence of complications such as difficult airway, desaturation, laryngospasm or bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch, palate and nasal septum as well as skeleton of the premaxilla and nasal septum during intubation is seen in approximately 90% of patients. To facilitate intubation, improve anesthesiology management and safety of pediatric patients with orofacial cleft, we will develop an individualized protective tray from a silicone material, that will be used during intubation to cover the defect of the alveolar arch and palate. A mold for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of the protective tray would facilitate intubation, decrease anesthesiologic complications and protect soft and hard tissues of the cleft palate and upper jaw during intubation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial.
Richtrová M, Košková O, Marcián P, Borák L, et al · · 2025 · PMID 40981509 · DOI 10.1080/07853890.2025.2561802
Verify or expand the search:
- PubMed search for NCT04422847
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cleft Lip and Palate
Currently open trials in the same condition.
- NCT06510881 — Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate · NA · recruiting
- NCT06284434 — Liposomal Bupivacaine Use in Alveolar Bone Graft Patients · Phase 3 · recruiting
- NCT06408337 — Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate. · Phase 1, PHASE2 · recruiting
- NCT06122805 — Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery · NA · recruiting
- NCT05796336 — Two Methods of Lip Taping as a Presurgical Orthopedic Appliance · NA · recruiting
Other Brno University Hospital trials
Trials by the same sponsor.
- NCT07468006 — Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children · recruiting
- NCT07280039 — Mortality and Muscle Mass Loss in Critically Ill Patients. · not yet recruiting
- NCT07279701 — The Effect of Near-infrared Spectroscopy on the Success of Peripheral Venous Access · NA · recruiting
- NCT07245654 — Monitoring the Depth of Anesthesia and Nociception During the Induction of General Anesthesia in Pediatric Patients · recruiting
- NCT07110012 — The Role of Simulation-based Training in Resident Curriculum in Anaesthesia and Intensive Care · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04422847 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brno University Hospital
- Last refreshed: 17 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04422847.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing