Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial

Cleft Lip and Palate Clinical Trial

Official title:

Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03011489
• Other study ID #: UCLP_Vacuum
• Status: Not yet recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: April 22, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Cairo University
• Contact: Khadega Ali Al Khateeb, Master
• Phone: 00201100739869
• Email: khadejaalkhateeb[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

Description:

newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group will receive Vacuum formed aligners while control group will not receive Vacuum formed aligners.

the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, standardized photographs for measurement of nasal changes and interlabial gap outcome and digital maxillary models for the maxillary dimension change outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Non-syndromic Infants with complete unilateral cleft lip and palate

• Infants less than 3 months of age

• Males and females.

• Infants with displaced alveolus

• Patients whose parents provided written consent for the study.

Exclusion Criteria:

• Patients above 3 months of age

• Syndromic, malnourished and systemically ill infants.

• Patients with bilateral cleft lip and palate.

• Incomplete Cleft lip.

• Medically compromised patients

• Patient's/guardians who will be unwilling to go through the PNAM therapy

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Vacuum formed aligners
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents' satisfaction	It will be measured by questionnaire	3 months
Secondary	Changes in Nasal morphology( Height, width, angulation of columella	It will be measured in mm by Standardized Digital photographs	3 months
Secondary	Changes in Interlabial gab	It will be measured in mm by Standardized Digital photographs	3 months
Secondary	Changes in Maxillary arch dimension	It will be measured in mm by Digital models	3 months