Cleft Lip and PalateNCT06211205
Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.
A study testing Customized 3D printed nostril retainer combined with lip taping and Lip taping in people with Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
Trial summary
Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants. The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and… Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Customized 3D printed nostril retainer combined with lip taping and Lip taping
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with age range from 1-30 days.
- Unilateral complete cleft lip and palate
- Medically free subjects.
- Both males and females.
Who cannot join
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Incomplete cleft lip.
- Patient with previous surgical lip repair or adhesion.
- Patients with previous presurgical infant orthopedic treatment.
- Medically compromised patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Orthodontics, Faculty of Dentistry, Cairo university
Cairo
Hana A Adawy, +01002061202, hana_adel@dentistry.cu.edu.eg
About this study
Official title: Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs. Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial.
Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.
The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.
- Conditions
- Cleft Lip and Palate
- Being tested
- Customized 3D printed nostril retainer combined with lip taping, Lip taping
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized 3D printed nostril retainer combined with lip tapingDevice
the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments
Lip tapingProcedure or surgery
the infants will receive lip tape to approximate the labial and alveolar segments
| Study group | Role | What they receive |
|---|---|---|
| Customized nostril retainer combined with lip taping | Experimental | Not described Receives: Device: Customized 3D printed nostril retainer combined with lip taping |
| Lip taping | Active comparator | Not described Receives: Procedure: Lip taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial esthetics
Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention.
This will be performed on a 3D scan for the infants and through calibrated photographs
Measured: 3 months
Secondary outcomes (1)
Maxillary arch changes
Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start30 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hana Adel Adawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211205
- Sponsor's protocol ID
- NCT26091993123
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs. Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06211205
- Acronym / sponsor ID
- NCT26091993123
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.
The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized nostril retainer combined with lip taping | Experimental | Device: Customized 3D printed nostril retainer combined with lip taping |
| Lip taping | Active comparator | Procedure: Lip taping |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with age range from 1-30 days.
- Unilateral complete cleft lip and palate
- Medically free subjects.
- Both males and females.
Key exclusion criteria (7 listed)
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Incomplete cleft lip.
- Patient with previous surgical lip repair or adhesion.
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 |
|---|---|---|
| Customized 3D printed nostril retainer combined with lip tapingthe infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments | Device | Customized nostril retainer combined with lip taping |
| Lip tapingthe infants will receive lip tape to approximate the labial and alveolar segments | Procedure or surgery | Lip taping |
Primary outcome
Nasolabial esthetics
Time frame: 3 months
Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention. This will be performed on a 3D scan for the infants and through calibrated photographs
1 secondary outcome
Maxillary arch changes
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized 3D printed nostril retainer combined with lip taping and Lip taping in people with Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hana A Adawy (+201002061202, hana_adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasolabial esthetics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2024.