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
|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
|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|
|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|
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.
- 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.
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
|Contact: Dina Y Girgis, B.D.Semail@example.com|
|Faculty of Oral and Dental Medicine- Cairo University||Recruiting|
|Cairo, Giza, Egypt, 11553|
|Contact: Dina Y Girgis, B.D.S +201278261226 firstname.lastname@example.org|
|Contact: Mamdouh A AboulHassan, PhD +201221022210 email@example.com|
|Principal Investigator: Dina Y Girgis, B.D.S|
|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|