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

April 22, 2017 updated by: Khadega Ali Al Khateeb, Cairo University
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vacuum formed aligners group
This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
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.
No Intervention: control group
This group will not receive any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' satisfaction
Time Frame: 3 months
It will be measured by questionnaire
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Nasal morphology( Height, width, angulation of columella
Time Frame: 3 months
It will be measured in mm by Standardized Digital photographs
3 months
Changes in Interlabial gab
Time Frame: 3 months
It will be measured in mm by Standardized Digital photographs
3 months
Changes in Maxillary arch dimension
Time Frame: 3 months
It will be measured in mm by Digital models
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 22, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCLP_Vacuum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cleft Lip and Palate

Clinical Trials on Vacuum formed aligners

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe