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Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.

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ClinicalTrials.gov Identifier: NCT03922438
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dina Yacoub Girgis, Cairo University

Brief Summary:
During primary cleft lip repair in patients who were born with cleft lip and palate, usage of cleft margin flap with anterior palatal closure will be done in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively.

Condition or disease Intervention/treatment Phase
Nasoalveolar Fistula (Defect) Procedure: usage of cleft margin flap with anterior palatal closure during primary cleft lip repair. Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study The eligible patients will be included in the study
Masking: None (Open Label)
Masking Description: No masking due to the nature of the intervention and the study design
Primary Purpose: Prevention
Official Title: Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study).
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cleft margin flap with anterior palatal closure
Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Procedure: usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Under general anesthesia, preparation of lip and palatal flaps will be done and then cleft margin flap which is designed to be inferiorly based will be used with anterior palatal closure in an attempt to decrease the incidence rate of naso-alveolar fistula (defect) that is usually occur and remain in those patients post-operatively.




Primary Outcome Measures :
  1. Naso-alveolar fistula [ Time Frame: 6 months postoperative. ]
    Naso-alveolar fistula will be assessed initially in the outpatient clinic by clinical examination and finally it will be re-assessed by usage of Methylene blue dye at time of cleft palate repair to assess the presence of any fistula.



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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non syndromic patients
  • Medically fit for Surgery
  • Patient with Primary, complete cleft lip
  • Patient's age younger than six months

Exclusion Criteria:

  • Patient with syndromic cleft lip
  • Previous operated cases
  • Incomplete cleft lip
  • Patient older than six months
  • Patients with any systemic condition

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): NCT03922438


Contacts
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Contact: Dina Y Girgis, B.D.S +201278061226 dina.yacoub@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of Oral and Dental Medicine- Cairo University Recruiting
Cairo, Giza, Egypt, 11553
Contact: Dina Y Girgis, B.D.S    +201278261226    dina.yacoub@dentistry.cu.edu.eg   
Contact: Mamdouh A AboulHassan, PhD    +201221022210    aboulhassanm2@gmail.com   
Principal Investigator: Dina Y Girgis, B.D.S         
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mohamed G Beheiri, PhD Faculty of Oral and Dental Medicine- Cairo University
Study Director: Mamdouh A AboulHassan, PhD Cairo University
Study Director: Khaled A Salah Eldein, PhD Faculty of Oral and Dental Medicine- Cairo University
Study Director: Sherif A Hassan, PhD Faculty of Oral and Dental Medicine- Cairo University
Principal Investigator: Dina Y Girgis, B.D.S Faculty of Oral and Dental Medicine- Cairo University

Additional Information:
Publications:
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Responsible Party: Dina Yacoub Girgis, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03922438     History of Changes
Other Study ID Numbers: CEBD-CU-2019-04-12
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina Yacoub Girgis, Cairo University:
Cleft lip and palate
Cleft lip
Cleft alveolus
Cheiloplasty
Nasoalveolar fistula

Additional relevant MeSH terms:
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Fistula
Cleft Lip
Pathological Conditions, Anatomical
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities