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出境医 / 临床实验 / Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Study Description
Brief Summary:
Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Bilateral Cleft Lip/Palate Device: Presurgical vacuum formed nasoalveolar molding aligners Device: Conventional Grayson acrylic formed nasoalveolar molding appliances Not Applicable

Detailed Description:

The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: single blinded
Primary Purpose: Treatment
Official Title: Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Presurgical vacuum formed nasoalveolar molding aligners group
In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks
 Device: Presurgical vacuum formed nasoalveolar molding aligners
at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
Experimental: conventional Grayson acrylic formed nasoalveolar molding appliances group
This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.
 Device: Conventional Grayson acrylic formed nasoalveolar molding appliances

at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance.

When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.
Outcome Measures
Primary Outcome Measures :
  1. Changes in the maxillary arch [ Time Frame: T1 and T2 (4- 6 months) ]
    they will be measured in mm by digital models


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-syndromic Infants with complete BCLP infants
  • Infants less than 1 month of age
  • Males and females.
  • Infants with displaced premaxilla
  • Patients whose parents provided written consent for the study.

Exclusion Criteria:

  • Patients above 1 month of age
  • Syndromic and systemically ill infants.
  • Patients with unilateral cleft lip and palate.
  • Incomplete Cleft lip.
  • Medically compromised patients
  • Patient's/guardians who will be unwilling to go through the PNAM therapy
Contacts and Locations

Contacts
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Contact: Khadega Ali Al Khateeb, PhD 00201100739869 khadejaalkhateeb@yahoo.com
Contact: Mohamed Abd El-Ghafour, Lecturer 00201007433288 m.abdelghafour@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: Mai Aboul Fotouh, lecturer    00201001884499    mai.aboulfotouh@dentistry.cu.edu.eg   
Contact: Mohamed Abd El-Ghafour, lecturer    00201007433288    m.abdelghafour@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Fatma Abdu Abdelsayed, Professor Cairo University
Tracking Information
First Submitted Date  ICMJE July 8, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021) 		Changes in the maxillary arch [ Time Frame: T1 and T2 (4- 6 months) ]
they will be measured in mm by digital models
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.
Official Title  ICMJE Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Brief Summary Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.
Detailed Description

The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
single blinded
Primary Purpose: Treatment
Condition  ICMJE
  • Cleft Lip and Palate
  • Bilateral Cleft Lip/Palate
Intervention  ICMJE
  • Device: Presurgical vacuum formed nasoalveolar molding aligners
    at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
  • Device: Conventional Grayson acrylic formed nasoalveolar molding appliances

    at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance.

    When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.
Study Arms  ICMJE
  • Experimental: Presurgical vacuum formed nasoalveolar molding aligners group
    In this group, all patients will receive 1-2 VF-NAM aligners incorporated with palatal screw in addition to taping from day 1 for 4-6 Months with follow-up every 3 weeks
    Intervention: Device: Presurgical vacuum formed nasoalveolar molding aligners
  • Experimental: conventional Grayson acrylic formed nasoalveolar molding appliances group
    This group will receive conventional Grayson acrylic formed nasoalveolar molding appliances without taping except some cases, with follow up every week for activation.
    Intervention: Device: Conventional Grayson acrylic formed nasoalveolar molding appliances
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2021) 		24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-syndromic Infants with complete BCLP infants
  • Infants less than 1 month of age
  • Males and females.
  • Infants with displaced premaxilla
  • Patients whose parents provided written consent for the study.

Exclusion Criteria:

  • Patients above 1 month of age
  • Syndromic and systemically ill infants.
  • Patients with unilateral cleft lip and palate.
  • Incomplete Cleft lip.
  • Medically compromised patients
  • Patient's/guardians who will be unwilling to go through the PNAM therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Khadega Ali Al Khateeb, PhD 00201100739869 khadejaalkhateeb@yahoo.com
Contact: Mohamed Abd El-Ghafour, Lecturer 00201007433288 m.abdelghafour@dentistry.cu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04966572
Other Study ID Numbers  ICMJE BCLP_ Grayson_ vacuum
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Khadega Ali Al Khateeb, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fatma Abdu Abdelsayed, Professor Cairo University
PRS Account Cairo University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP