Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

Cairo University (CU)

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Device: Modified Nasoalveolar molding; Device: Taping; Device: CAD/NAM

Study type: Interventional

Funder types: Other

Identifiers

NCT02845193

CEBD-2016-07-172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 7 to 30 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 4 patient groups

Modified Nasoalveolar molding group

Experimental group

Description:

This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.

Treatment:

Device: Modified Nasoalveolar molding

Taping group

Experimental group

Description:

Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.

Treatment:

Device: Taping

Control group

No Intervention group

Description:

This group will not receive any treatment.

CAD/NAM group

Experimental group

Description:

Computer Aided Designed Nasoalveolar molding and 3D printed.

Treatment:

Device: CAD/NAM