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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: -
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| normal children | No Intervention | normal children which will be compared with groups 1 and 2 for results evaluation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasoalveolar molding in unilateral cleft lip and palate | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior ends of alveolar crest | width between the most posterior ends of the alveolar crest in the greater segment and lesser segment | 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 | 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) | 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) | 3 months |
| Angulation of maxilla | Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alar base width | Total width correction of alar base width. | 3 months |
| Columella length. | Columella length correction | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed F Ahmed, Master | Contact | 00201009050985 | Ahmedfarghly0@gmail.com | |
| Adel F Hassan, Phd | Contact | 00201124591323 | Adelfathy@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Adel F Hassan, Phd | Fucalty of dental medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dental medicine | Cairo | 4050113 | Egypt |
all IPD that underlie results in a publication
4 months
all IPD that underlie results in a publication
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| ID | Term |
|---|---|
| D000084982 | Nasoalveolar Molding |
| ID | Term |
|---|---|
| D011300 | Preoperative Care |
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| Columella angle deviation. | Columella angle deviation correction | 3 months |
| Nostril height and width on the cleft side. | Nostril height and width on the cleft side correction | 3 months |
| Nostril height and width on the non-cleft side | Nostril height and width on the non-cleft side correction | 3 months |
| Nasal ridge deviation. | Nasal ridge deviation correction | 3 months |
| Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University | Cairo | 4450113 | Egypt |
|
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013514 |
| Surgical Procedures, Operative |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |