Cleft Lip and PalateNCT06451276
The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate
A study testing Nasoalveolar molding in unilateral cleft lip and palate in people with Cleft Lip and Palate, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate. objectives: - 1. Read more about this study
- Who is it for?
- Ages 7 days to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Nasoalveolar molding in unilateral cleft lip and palate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jul 2024to 20 Aug 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 7 days to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 1- 8 weeks.
- Gender: male and female.
- Patients with a unilateral cleft alveolus and lip.
- No developmental syndromes or atypical cleft pathology in medical history.
- No previous history of unilateral CLP correction.
- Motivated parents toward the treatment.
Who cannot join
- Patients with a bilateral cleft alveolus and lip
- Syndromic patient
- Uncooperative caregiver
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of dental medicine
Cairo, 4050113
Ahmed Ahmed, Master, 00201009050985, Ahmedfarghly0@gmail.com
Adel F Hassan, Phd
Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University
Cairo, 4450113
Ahmed Ahmed, Master, +1917-528-5809, Ahmedfarghly0@gmail.com
Adel Hassan, Phd, +201124591323, Adelfathy@azhar.edu.eg
About this study
Official title: The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Alveolar Ridge, Nasal and Labial Growths in Children With Unilateral Cleft Lip and Palate
The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate.
objectives: -
- Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.
- Evaluation of the nasal symmetry.
Read the detailed description
cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. Unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. Additionally, it predominantly affects males, with a male-to-female ratio of 2:1. Common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. Peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. Additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side.
Conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. However, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. Therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. The introduction of the presurgical Nasoalveolar molding (NAM) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . These interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.
- Conditions
- Cleft Lip and Palate
- Being tested
- Nasoalveolar molding in unilateral cleft lip and palate
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasoalveolar molding in unilateral cleft lip and palateDevice
Also called NAM
compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate
| Study group | Role | What they receive |
|---|---|---|
| Adhesive nasoalveolar molding (GS-NAM) | Active comparator | 3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D (3 dimensional ) printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm Receives: Device: Nasoalveolar molding in unilateral cleft lip and palate |
| Conventional nasoalveolar molding | Experimental | (positive control group) comprises 10 cases of unilateral cleft lip and palate that will be scheduled for construction of 3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm Receives: Device: Nasoalveolar molding in unilateral cleft lip and palate |
| normal children | No intervention | normal children which will be compared with groups 1 and 2 for results evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior ends of alveolar crest
width between the most posterior ends of the alveolar crest in the greater segment and lesser segment
Measured: 3 months
Middle ends of alveolar crest
width between the middle parts of the cleft palate (The intersection points between the palatally extended buccal frenum sulcus line and the palatal gingival groove in the greater and lesser segment
Measured: 3 months
Anterior ends of alveolar crest
The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)
Measured: 3 months
Mid line of maxilla
Inc-Sagittal: - Perpendicular distance from Inc point (The intersection points between the labial frenum-incisive papilla point line and the alveolar crest of the premaxilla in the greater segment) to sagittal line (The perpendicular line to the PG-PL line)
Measured: 3 months
Angulation of maxilla
Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line
Measured: 3 months
Secondary outcomes (6)
Alar base width
Total width correction of alar base width.
Measured: 3 months
Columella length.
Columella length correction
Measured: 3 months
Columella angle deviation.
Columella angle deviation correction
Measured: 3 months
Nostril height and width on the cleft side.
Nostril height and width on the cleft side correction
Measured: 3 months
Nostril height and width on the non-cleft side
Nostril height and width on the non-cleft side correction
Measured: 3 months
Nasal ridge deviation.
Nasal ridge deviation correction
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 posted11 Jun 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Aug 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 Al-Azhar 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
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Farghly Abdelnaeem Ahmed, Al-Azhar University
- Investigators
- Adel F Hassan, Phd, Study director, Fucalty of dental medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451276
- Sponsor's protocol ID
- NAM in unilateral cleft
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Alveolar Ridge, Nasal and Labial Growths in Children With Unilateral Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT06451276
- Acronym / sponsor ID
- NAM in unilateral cleft
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 11 Jun 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 present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate.
objectives: -
- Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.
- Evaluation of the nasal symmetry.
Detailed description
cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. Unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. Additionally, it predominantly affects males, with a male-to-female ratio of 2:1. Common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. Peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. Additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side.
Conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. However, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. Therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. The introduction of the presurgical Nasoalveolar molding (NAM) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . These interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adhesive nasoalveolar molding (GS-NAM) | Active comparator | Device: Nasoalveolar molding in unilateral cleft lip and palate3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D (3 dimensional ) printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm |
| Conventional nasoalveolar molding | Experimental | Device: Nasoalveolar molding in unilateral cleft lip and palate(positive control group) comprises 10 cases of unilateral cleft lip and palate that will be scheduled for construction of 3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm |
| normal children | No intervention | –normal children which will be compared with groups 1 and 2 for results evaluation |
Who may qualify
- Ages
- 7 days to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 1- 8 weeks.
- Gender: male and female.
- Patients with a unilateral cleft alveolus and lip.
- No developmental syndromes or atypical cleft pathology in medical history.
- No previous history of unilateral CLP correction.
Key exclusion criteria (3 listed)
- Patients with a bilateral cleft alveolus and lip
- Syndromic patient
- Uncooperative caregiver
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 molding in unilateral cleft lip and palateAlso: NAMcompare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate | Device | Adhesive nasoalveolar molding (GS-NAM), Conventional nasoalveolar molding |
Primary outcome
Posterior ends of alveolar crest
Time frame: 3 months
width between the most posterior ends of the alveolar crest in the greater segment and lesser segment
Middle ends of alveolar crest
Time frame: 3 months
width between the middle parts of the cleft palate (The intersection points between the palatally extended buccal frenum sulcus line and the palatal gingival groove in the greater and lesser segment
Anterior ends of alveolar crest
Time frame: 3 months
The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)
Mid line of maxilla
Time frame: 3 months
Inc-Sagittal: - Perpendicular distance from Inc point (The intersection points between the labial frenum-incisive papilla point line and the alveolar crest of the premaxilla in the greater segment) to sagittal line (The perpendicular line to the PG-PL line)
Angulation of maxilla
Time frame: 3 months
Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line
6 secondary outcomes
Alar base width
Time frame: 3 months
Columella length.
Time frame: 3 months
Columella angle deviation.
Time frame: 3 months
Nostril height and width on the cleft side.
Time frame: 3 months
Nostril height and width on the non-cleft side
Time frame: 3 months
Nasal ridge deviation.
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 11 Jun 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Adel F Hassan, Phd study director
Fucalty of dental medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasoalveolar molding in unilateral cleft lip and palate in people with Cleft Lip and Palate, run by Al-Azhar University at 2 sites 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 6 inclusion and 3 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ahmed F Ahmed, Master (00201009050985, Ahmedfarghly0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior ends of alveolar crest (time frame: 3 months). The study lists 5 primary outcomes in all. 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 Jun 2024.