Cleft Lip and Palate
Conditions
Brief summary
The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.
Detailed description
In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.
Interventions
DEVICEModified Nasoalveolar molding
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).
DEVICETaping
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
DEVICECAD/NAM
computer aided design NAM
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Days to 30 Days
Healthy volunteers
Yes
Inclusion criteria
1. Infants with age range from 7 - 30 days. 2. Unilateral complete cleft lip and alveolus. 3. Presence of unilateral cleft palate. 4. Medically free subjects. 5. Both males and females.
Exclusion criteria
1. Patients older than 30 days. 2. Syndromic patients with other defects in addition to cleft lip and palate. 3. Patients with bilateral cleft lip and palate. 4. Incomplete Cleft lip. 5. Medically compromised patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parents' satisfaction | 3 months | It will be assessed using Questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Esthetics: b- Nostril width | 3 months | It will be measured in mm by Digital ruler on the images using a software. |
| Nasal Esthetics: c- Nasal sill height | 3 months | It will be measured in mm by Digital ruler on the images using a software. |
| Nasal Esthetics: a- Nostril height | 3 months | It will be measured in mm by Digital ruler on the images using a software. |
| Interlabial gap | 3 months | It will be measured in mm by Digital ruler on the images using a software. |
| Maxillary Arch Dimension | 3 months | It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes. |
| Nasal Esthetics: d- Nostril area | 3 months | It will be measured on the images in mm 2 (square) using a software measuring area. |
Countries
Egypt
Outcome results
None listed