Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451276
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-31
Brief Title:
The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 21 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None