Cleft Lip and Palate
Conditions
Brief 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. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point. 2. 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.
Interventions
DEVICENasoalveolar molding in unilateral cleft lip and palate
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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Days to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Patients with a bilateral cleft alveolus and lip * Syndromic patient * Uncooperative caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterior ends of alveolar crest | 3 months | width between the most posterior ends of the alveolar crest in the greater segment and lesser segment |
| Middle ends of alveolar crest | 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 | 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 | 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 | 3 months | Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alar base width | 3 months | Total width correction of alar base width. |
| Nasal ridge deviation. | 3 months | Nasal ridge deviation correction |
| Columella length. | 3 months | Columella length correction |
| Columella angle deviation. | 3 months | Columella angle deviation correction |
| Nostril height and width on the cleft side. | 3 months | Nostril height and width on the cleft side correction |
| Nostril height and width on the non-cleft side | 3 months | Nostril height and width on the non-cleft side correction |
Countries
Egypt
Contacts
Primary ContactAhmed F Ahmed, Master
Backup ContactAdel F Hassan, Phd
Outcome results
None listed