The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate
- Conditions
- Cleft Lip and Palate
- Interventions
- Device: Nasoalveolar molding in unilateral cleft lip and palate
- Registration Number
- NCT06451276
- Lead Sponsor
- Al-Azhar University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- Patients with a bilateral cleft alveolus and lip
- Syndromic patient
- Uncooperative caregiver
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adhesive nasoalveolar molding (GS-NAM) Nasoalveolar molding in unilateral cleft lip and palate 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 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
- Primary Outcome Measures
Name Time Method Posterior ends of alveolar crest 3 months width between the most posterior ends of the alveolar crest in the greater segment 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)
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)
Angulation of maxilla 3 months Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line
- Secondary Outcome Measures
Name Time Method Alar base width 3 months Total width correction of alar base width.
Columella angle deviation. 3 months Columella angle deviation correction
Columella length. 3 months Columella length 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
Nasal ridge deviation. 3 months Nasal ridge deviation correction
Trial Locations
- Locations (2)
Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University
🇪🇬Cairo, Egypt
Faculty of dental medicine
🇪🇬Cairo, Egypt