Cleft Lip and Palate3D obturatorNCT04422847
Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
A study testing 3D obturator in people with Cleft Lip and Palate, run by Brno University Hospital at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- 3D obturator
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period)
- Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age.
Who cannot join
- unilateral or bilateral cleft lip without cleft alveolus
- patients with genetically confirmed syndrome disability
- orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae)
- patients with atypical clefts of the face
- patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age
- patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18 months of age
Show all 12Show fewer
- patients with submucous cleft palate
- patients with airways secured preoperatively
- patients on artificial lung ventilation
- patients with coagulopathy, thrombocytopenia/thrombocytopathy
- patients at risk of malignant hyperthermia
- patients for whom the consent of legal representatives to the research project has not been obtained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University hospital Brno
Brno, Jihomoravská Kraj, 62500
Petr Štourač, doc.MD.Ph.D, 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD, 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
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.
Read the detailed description
After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria for whom primary surgery for a cleft facial defect will be indicated.
Patients will be divided into two groups based on the type of surgery. Group 1 will include patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age. Group 2 will include patients with isolated cleft palate (ICP) and patients with U/BCLAP who underwent primary cleft reconstruction between 6 and 18 months of age.
Patients in the pediatric plastic surgery clinic of the Department of Pediatric Surgery, Orthopedics and Traumatology will be randomized with a 1:1 allocation based on the day of operation to the intervention group (3D protective obturator) and the control group (standard procedure without the 3D obturator). Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used.
The main objective of the research will be to find out how the use of a protective obturator (splint) will improve the protection of tissues at the cleft site and whether intubation will be facilitated in pediatric patients with orofacial clefts with congenital atypical anatomical conditions in the oral cavity.
- Conditions
- Cleft Lip and Palate
- Being tested
- 3D obturator
- Keywords
- 3D print, Cleft surgery, Paediatric, Airway
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D obturatorDevice
Also called 3D printer obturator
Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer
| Study group | Role | What they receive |
|---|---|---|
| intervention group (3D protective obturator) | Experimental | Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used. Receives: Device: 3D obturator |
| control group | No intervention | The standard procedure without the 3D obturator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of oral tissue injury during intubation
specifically presence of petechiae, bleeding or soft tissue swelling after intubation in the entire cleft defect area, possibly premaxilla fracture in total cleft patients as a result of manipulation of the laryngoscope in the oral cavity
Measured: Intraoperatively (after successful intubation)
Secondary outcomes (1)
Cormack-Lehane score
evaluation of the laryngoscopic image during intubation evaluated by the Cormack-Lehane score with or without the use of the protective tray. Cormack-Lehane scale range from 1 (ideal view - vocal cords) to 4 (the worst view of aditus laryngis, only the soft palate visible). For proper archiving of the intubation process, a photodocumentation of the laryngoscopic image during intubation will be taken for each patient using a video laryngoscope.
Measured: Intraoperatively (during intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be randomized according to the interventional and control goup according to the day of surgery. The allocation between the groups will be 1:1
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University of Technology, Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, prof. MD., Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422847
- Sponsor's protocol ID
- 3D Obturator
- Acronym
- 3D obturator
- Status last verified
- Nov 2025
- First submitted
- 5 Jun 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Richtrova M, Koskova O, Marcian P, Borak L, Bonischova T, Fabian D, Janku M, Joukal M, Vymazalova K, Stourac P. Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial. Ann Med. 2025 Dec;57(1):2561802. doi: 10.1080/07853890.2025.2561802. Epub 2025 Sep 22.
PubMed 40981509
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
- ClinicalTrials.gov ID
- NCT04422847
- Acronym / sponsor ID
- 3D obturator / 3D Obturator
- Conditions
- Cleft Lip and Palate
- Keywords
- 3D print, Cleft surgery, Paediatric, Airway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Brno University of Technology, Masaryk University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria for whom primary surgery for a cleft facial defect will be indicated.
Patients will be divided into two groups based on the type of surgery. Group 1 will include patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age. Group 2 will include patients with isolated cleft palate (ICP) and patients with U/BCLAP who underwent primary cleft reconstruction between 6 and 18 months of age.
Patients in the pediatric plastic surgery clinic of the Department of Pediatric Surgery, Orthopedics and Traumatology will be randomized with a 1:1 allocation based on the day of operation to the intervention group (3D protective obturator) and the control group (standard procedure without the 3D obturator). Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used.
The main objective of the research will be to find out how the use of a protective obturator (splint) will improve the protection of tissues at the cleft site and whether intubation will be facilitated in pediatric patients with orofacial clefts with congenital atypical anatomical conditions in the oral cavity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient will be randomized according to the interventional and control goup according to the day of surgery. The allocation between the groups will be 1:1
| Arm | Type | Receives |
|---|---|---|
| intervention group (3D protective obturator) | Experimental | Device: 3D obturatorPatients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used. |
| control group | No intervention | –The standard procedure without the 3D obturator. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period)
- Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age.
Key exclusion criteria (12 listed)
- unilateral or bilateral cleft lip without cleft alveolus
- patients with genetically confirmed syndrome disability
- orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae)
- patients with atypical clefts of the face
- patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D obturatorAlso: 3D printer obturatorBased on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer | Device | intervention group (3D protective obturator) |
Primary outcome
Degree of oral tissue injury during intubation
Time frame: Intraoperatively (after successful intubation)
specifically presence of petechiae, bleeding or soft tissue swelling after intubation in the entire cleft defect area, possibly premaxilla fracture in total cleft patients as a result of manipulation of the laryngoscope in the oral cavity
1 secondary outcome
Cormack-Lehane score
Time frame: Intraoperatively (during intubation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 40981509Richtrova M, Koskova O, Marcian P, Borak L, Bonischova T, Fabian D, Janku M, Joukal M, Vymazalova K, Stourac P. Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial. Ann Med. 2025 Dec;57(1):2561802. doi: 10.1080/07853890.2025.2561802. Epub 2025 Sep 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Štourač, prof. MD., Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D obturator in people with Cleft Lip and Palate, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela Richtorvá, MD. (532234693 ext. 00420, richtrova.michaela@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of oral tissue injury during intubation (time frame: Intraoperatively (after successful intubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.