CompletedNot Applicable

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

Egypt63 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range7 Days – 30 Days

SexALL

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Inclusion criteria

✓. Infants with age range from 7 - 30 days.
✓. Unilateral complete cleft lip and alveolus.
✓. Presence of unilateral cleft palate.
✓. Medically free subjects.
✓. Both males and females.

Exclusion criteria

✕. Patients older than 30 days.
✕. Syndromic patients with other defects in addition to cleft lip and palate.
✕. Patients with bilateral cleft lip and palate.
✕. Incomplete Cleft lip.
✕. Medically compromised patients.

What they're measuring

Parents' satisfaction

Timeframe: 3 months

Trial details

NCT IDNCT02845193

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Cleft Lip and Palate trials