Cleft Lip and/or PalateNCT06494098
Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants
A study testing Nasoalveolar Molding and Addition silicone impression in people with Cleft Lip and/or Palate and Cleft Lip Bilateral, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of: 1. Decreasing cleft gap. 2. Attaining columellar length. 3. Effect on maxillary growth. 4. Read more about this study
- Who is it for?
- Ages 2 weeks to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and/or Palate, Cleft Lip Bilateral
- What is being tested?
- Nasoalveolar Molding and Addition silicone impression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2024to 15 Sep 2024
- 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 2 weeks to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The age range from 14 -30 days after birth.
- Has complete cleft lip and palate.
- Parents acceptance.
- Medically free infants.
Who cannot join
- Syndromic patients.
- Medically compromised patients contradicting operation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:
- Decreasing cleft gap.
- Attaining columellar length.
- Effect on maxillary growth.
- Treatment Duration.
- Parents acceptance.
- Conditions
- Cleft Lip and/or Palate, Cleft Lip Bilateral
- Being tested
- Nasoalveolar Molding, Addition silicone impression
- Keywords
- Cleft palate, Cleft Lip and/or Palate, Nasoalveolar Molding
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasoalveolar MoldingProcedure or surgery
presurgical orthopedics
Addition silicone impressionDiagnostic test
diagnostic impression for maxillary arch and nose
| Study group | Role | What they receive |
|---|---|---|
| NAM group | Experimental | Not described Receives: Procedure: Nasoalveolar Molding; Diagnostic Test: Addition silicone impression |
| MNAM | Experimental | Not described Receives: Procedure: Nasoalveolar Molding; Diagnostic Test: Addition silicone impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attaining columellar length
the length of columella has increased after nasoalveolar molding orthopedic treatment
Measured: 3 month
Secondary outcomes (1)
Treatment Duration
the time taken to decrease the alveolar cleft gap and to lengthen the columella
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start16 Jun 2024
- Primary completion1 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and/or PalateStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494098
- Sponsor's protocol ID
- M02204023PP
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants
- ClinicalTrials.gov ID
- NCT06494098
- Acronym / sponsor ID
- M02204023PP
- Conditions
- Cleft Lip and/or Palate, Cleft Lip Bilateral
- Keywords
- Cleft palate, Cleft Lip and/or Palate, Nasoalveolar Molding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 10 Jul 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.
The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:
- Decreasing cleft gap.
- Attaining columellar length.
- Effect on maxillary growth.
- Treatment Duration.
- Parents acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAM group | Experimental | Procedure: Nasoalveolar Molding, Diagnostic Test: Addition silicone impression |
| MNAM | Experimental | Procedure: Nasoalveolar Molding, Diagnostic Test: Addition silicone impression |
Who may qualify
- Ages
- 2 weeks to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The age range from 14 -30 days after birth.
- Has complete cleft lip and palate.
- Parents acceptance.
- Medically free infants.
Key exclusion criteria (2 listed)
- Syndromic patients.
- Medically compromised patients contradicting operation.
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 |
|---|---|---|
| Nasoalveolar Moldingpresurgical orthopedics | Procedure or surgery | MNAM, NAM group |
| Addition silicone impressiondiagnostic impression for maxillary arch and nose | Diagnostic test | MNAM, NAM group |
Primary outcome
Attaining columellar length
Time frame: 3 month
the length of columella has increased after nasoalveolar molding orthopedic treatment
1 secondary outcome
Treatment Duration
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasoalveolar Molding and Addition silicone impression in people with Cleft Lip and/or Palate and Cleft Lip Bilateral, run by Mansoura 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 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: finished, as of the sponsor's last update on 11 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attaining columellar length (time frame: 3 month). 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 11 May 2025.