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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorAl-Azhar University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a bilateral cleft alveolus and lip

Syndromic patient

Uncooperative caregiver

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nasoalveolar molding in unilateral cleft lip and palate

    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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Adhesive nasoalveolar molding (GS-NAM)Active comparator 1 intervention
Group B: Conventional nasoalveolar moldingExperimental treatment 1 intervention
Group C: normal childrenNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Posterior ends of alveolar crest

width between the most posterior ends of the alveolar crest in the greater segment and lesser segment

Time frame
3 months
2

Middle ends of alveolar crest

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

Time frame
3 months
3

Anterior ends of alveolar crest

The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)

Time frame
3 months
4

Mid line of maxilla

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)

Time frame
3 months

Secondary outcomes

1

Alar base width

Total width correction of alar base width.

Time frame
3 months
2

Columella length.

Columella length correction

Time frame
3 months
3

Columella angle deviation.

Columella angle deviation correction

Time frame
3 months
4

Nostril height and width on the cleft side.

Nostril height and width on the cleft side correction

Time frame
3 months

Other outcomes

Sponsors and contacts

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