Cleft Lip and Cleft PalatePhase 1D-NAMNCT06589453
Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants
A Phase 1 study testing Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants and Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants in people with Cleft Lip and Cleft Palate, run by Cairo University.
Trial summary
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Cleft Lip and Cleft Palate
- What is being tested?
- Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants and Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Oct 2026
- Phase
- Phase 1
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-syndromic Infants with complete BCLP infants
- Infants less than 1 month of age.
- Males and females.
- Infants with displaced premaxilla
- Patients whose parents provided written consent for the study.
Who cannot join
- Patients above 1 month of age.
- Syndromic and systemically ill infants.
- Patients with unilateral cleft lip and palate.
- Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
- Medically compromised patients
- Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.
Read the detailed description
The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.
- Conditions
- Cleft Lip and Cleft Palate
- Being tested
- Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants, Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants
- Keywords
- Cleft lip and palate
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infantsDevice
This is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants.
Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infantsDevice
Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants
| Study group | Role | What they receive |
|---|---|---|
| Nasal stent with Digital Nasoalveolar molding | Active comparator | Not described Receives: Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants |
| Nasal elevator with Digital Nasoalveolar molding | Experimental | Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants. Receives: Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasolabial esthetics
Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.
Measured: 4-6 months
Secondary outcomes (1)
Maxillary arch changes
Maxillary arch changes will be assessed in millimeters using maxillary digital models.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion1 Oct 2026 (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 Cleft 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, : Donia Ayman Ahmed Ezzeldin ElSayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589453
- Sponsor's protocol ID
- D-NAM 2024
- Acronym
- D-NAM
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06589453
- Acronym / sponsor ID
- D-NAM / D-NAM 2024
- Conditions
- Cleft Lip and Cleft Palate
- Keywords
- Cleft lip and palate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Sep 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.
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.
Detailed description
The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal stent with Digital Nasoalveolar molding | Active comparator | Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants |
| Nasal elevator with Digital Nasoalveolar molding | Experimental | Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infantsNasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Non-syndromic Infants with complete BCLP infants
- Infants less than 1 month of age.
- Males and females.
- Infants with displaced premaxilla
- Patients whose parents provided written consent for the study.
Key exclusion criteria (6 listed)
- Patients above 1 month of age.
- Syndromic and systemically ill infants.
- Patients with unilateral cleft lip and palate.
- Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
- Medically compromised patients
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 |
|---|---|---|
| Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infantsThis is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants. | Device | Nasal elevator with Digital Nasoalveolar molding |
| Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infantsNasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants | Device | Nasal stent with Digital Nasoalveolar molding |
Primary outcome
Nasolabial esthetics
Time frame: 4-6 months
Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.
1 secondary outcome
Maxillary arch changes
Time frame: 4-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants and Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants in people with Cleft Lip and Cleft Palate, run by Cairo University.
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 5 inclusion and 6 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Donia Ayman Ahmed Ezzeldin, PhD (00201001200089, donia.ayman@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: 4-6 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 17 Oct 2024.