Clinical trial NCT06451276: The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Posterior ends of alveolar crest
timeFrame: 3 months
measure: Middle ends of alveolar crest
timeFrame: 3 months
measure: Anterior ends of alveolar crest
timeFrame: 3 months
measure: Mid line of maxilla
timeFrame: 3 months
measure: Angulation of maxilla
timeFrame: 3 months
Secondary outcomes:
measure: Alar base width
timeFrame: 3 months
measure: Columella length.
timeFrame: 3 months
measure: Columella angle deviation.
timeFrame: 3 months
measure: Nostril height and width on the cleft side.
timeFrame: 3 months
measure: Nostril height and width on the non-cleft side
timeFrame: 3 months
measure: Nasal ridge deviation.
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University
Study officials:
affiliation: Fucalty of dental medicine
name: Adel F Hassan, Phd
role: STUDY_DIRECTOR
References: