Back to resultsParent'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
Primary Purpose
Cleft Lip and Palate
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vacuum formed aligners
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vacuum formed aligners group
control group
Arm Description
This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
This group will not receive any treatment
Outcomes
Primary Outcome Measures
Parents' satisfaction
It will be measured by questionnaire
Secondary Outcome Measures
Changes in Nasal morphology( Height, width, angulation of columella
It will be measured in mm by Standardized Digital photographs
Changes in Interlabial gab
It will be measured in mm by Standardized Digital photographs
Changes in Maxillary arch dimension
It will be measured in mm by Digital models
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011489
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vacuum formed aligners group
Arm Type
Experimental
Arm Description
This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
Arm Title
control group
Arm Type
No Intervention
Arm Description
This group will not receive any treatment
Intervention Type
Device
Intervention Name(s)
Vacuum formed aligners
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parents' satisfaction
Description
It will be measured by questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in Nasal morphology( Height, width, angulation of columella
Description
It will be measured in mm by Standardized Digital photographs
Time Frame
3 months
Title
Changes in Interlabial gab
Description
It will be measured in mm by Standardized Digital photographs
Time Frame
3 months
Title
Changes in Maxillary arch dimension
Description
It will be measured in mm by Digital models
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khadega Ali Al Khateeb, Master
Phone
00201100739869
Email
khadejaalkhateeb@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Abdu Abdelsayed, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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