Cleft LipNCT06411444
Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance
A study testing Grape Design Nasal Stent in people with Cleft Lip and Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate. Read more about this study
- Who is it for?
- Ages 0 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip, Cleft Lip and Palate
- What is being tested?
- Grape Design Nasal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 15 Apr 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 0 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Complete unilateral cleft lip and palate.
- younger than 30 day old
Who cannot join
- Syndromic patients.
- older than 30 days old.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry
Cairo, 00202
Mohamed Abd-El-Ghafour, PhD, +2 01007433288, m.abdelghafour@dentistry.cu.edu.eg
About this study
Official title: Effectiveness of Kidney Shaped Versus Grape Design Nasal Stents in Conjunction With Nasoalveolar Molding Appliance on Nasolabial Esthetics in Infants With Complete Unilateral Cleft Lip and Palate: A Randomized Clinical Trial
This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.
- Conditions
- Cleft Lip, Cleft Lip and Palate
- Being tested
- Grape Design Nasal Stent
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Design Nasal StentDevice
Grape Design Nasal Stent
| Study group | Role | What they receive |
|---|---|---|
| Kidney Shaped Nasal Stent | Active comparator | Conventional NAM with kidney shaped nasal stent added to it. Receives: Device: Grape Design Nasal Stent |
| Grape Design Nasal Stent | Experimental | Conventional NAM with grape shaped nasal stent added to it. Receives: Device: Grape Design Nasal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nase and lip esthetics
Measuring linear measurements on 2D photos.
Measured: Photos are planned to be taken before starting the treatment and right after finishing it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd El-Ghafour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411444
- Sponsor's protocol ID
- 001
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kidney Shaped Versus Grape Design Nasal Stents in Conjunction With Nasoalveolar Molding Appliance on Nasolabial Esthetics in Infants With Complete Unilateral Cleft Lip and Palate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06411444
- Acronym / sponsor ID
- 001
- Conditions
- Cleft Lip, Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 13 May 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.
This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Shaped Nasal Stent | Active comparator | Device: Grape Design Nasal StentConventional NAM with kidney shaped nasal stent added to it. |
| Grape Design Nasal Stent | Experimental | Device: Grape Design Nasal StentConventional NAM with grape shaped nasal stent added to it. |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Complete unilateral cleft lip and palate.
- younger than 30 day old
Key exclusion criteria (2 listed)
- Syndromic patients.
- older than 30 days old.
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 |
|---|---|---|
| Grape Design Nasal StentGrape Design Nasal Stent | Device | Grape Design Nasal Stent, Kidney Shaped Nasal Stent |
Primary outcome
Nase and lip esthetics
Time frame: Photos are planned to be taken before starting the treatment and right after finishing it.
Measuring linear measurements on 2D photos.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- 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. 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 Grape Design Nasal Stent in people with Cleft Lip and 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 2 inclusion and 2 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 13 May 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 Mohamed Abd-El-Ghafour, PhD (01007433288, m.abdelghafour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nase and lip esthetics (time frame: Photos are planned to be taken before starting the treatment and right after finishing it.). 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 13 May 2024.