Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011489
Recruitment Status : Unknown
Verified April 2017 by Khadega Ali Al Khateeb, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Khadega Ali Al Khateeb, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Device: Vacuum formed aligners Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Parents' satisfaction [ Time Frame: 3 months ]
    It will be measured by questionnaire


Secondary Outcome Measures :
  1. Changes in Nasal morphology( Height, width, angulation of columella [ Time Frame: 3 months ]
    It will be measured in mm by Standardized Digital photographs

  2. Changes in Interlabial gab [ Time Frame: 3 months ]
    It will be measured in mm by Standardized Digital photographs

  3. Changes in Maxillary arch dimension [ Time Frame: 3 months ]
    It will be measured in mm by Digital models



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011489


Contacts
Layout table for location contacts
Contact: Khadega Ali Al Khateeb, Master 00201100739869 khadejaalkhateeb@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Fatma Abdu Abdelsayed, professor Cairo University

Layout table for additonal information
Responsible Party: Khadega Ali Al Khateeb, Master student, faculty of oral and dental medicine, Cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03011489     History of Changes
Other Study ID Numbers: UCLP_Vacuum
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities