The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-20

Study Completion Date

2025-08-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Adhesive nasoalveolar molding (GS-NAM)

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

Group Type ACTIVE_COMPARATOR

Nasoalveolar molding in unilateral cleft lip and palate

Intervention Type DEVICE

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

Conventional nasoalveolar molding

(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

Group Type EXPERIMENTAL

Nasoalveolar molding in unilateral cleft lip and palate

Intervention Type DEVICE

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

normal children

normal children which will be compared with groups 1 and 2 for results evaluation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nasoalveolar 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

Intervention Type DEVICE

Other Intervention Names

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NAM

Eligibility Criteria

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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.