An interventional study of Nasoalveolar molding in unilateral cleft lip and palate in Cleft Lip and Palate, sponsored by Al-Azhar University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 7 Days to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 116 interventional studies indexed under Cleft Lip.
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Exclusion Criteria:
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
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
Device: Nasoalveolar molding in unilateral cleft lip and palate
normal children which will be compared with groups 1 and 2 for results evaluation
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
Also known as: NAM
Posterior ends of alveolar crest
width between the most posterior ends of the alveolar crest in the greater segment and lesser segment
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 3 months
Angulation of maxilla
Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line
Time frame: 3 months
Alar base width
Total width correction of alar base width.
Time frame: 3 months
Columella length.
Columella length correction
Time frame: 3 months
Columella angle deviation.
Columella angle deviation correction
Time frame: 3 months
Nostril height and width on the cleft side.
Nostril height and width on the cleft side correction
Time frame: 3 months
Nostril height and width on the non-cleft side
Nostril height and width on the non-cleft side correction
Time frame: 3 months
Nasal ridge deviation.
Nasal ridge deviation correction
Time frame: 3 months
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Clinical study report, Analytic code
Time frame: 4 months
Access criteria: all IPD that underlie results in a publication
Data sharing details ↗ · gmail.com
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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