| 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 |
| Allocation: | N/A |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cleft margin flap with anterior palatal closure
Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
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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.
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| Ages Eligible for Study: | 2 Months to 6 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Dina Y Girgis, B.D.S | +201278061226 | dina.yacoub@dentistry.cu.edu.eg |
| Egypt | |
| Faculty of Oral and Dental Medicine- Cairo University | Recruiting |
| Cairo, Giza, Egypt, 11553 | |
| Contact: Dina Y Girgis, B.D.S +201278061226 dina.yacoub@dentistry.cu.edu.eg | |
| Contact: Mamdouh A AboulHassan, PhD +201221022210 aboulhassanm2@gmail.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 |
| Tracking Information | ||||||||||||||||
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| First Submitted Date ICMJE | April 15, 2019 | |||||||||||||||
| First Posted Date ICMJE | April 22, 2019 | |||||||||||||||
| Last Update Posted Date | November 27, 2019 | |||||||||||||||
| Actual Study Start Date ICMJE | October 10, 2018 | |||||||||||||||
| Estimated Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | |||||||||||||||
| Current Primary Outcome Measures ICMJE |
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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| Original Primary Outcome Measures ICMJE |
Naso-alveolar fistula (defect) [ Time Frame: 6 months postoperative. ] Naso-alveolar fistula (defect) 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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| 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 | Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect. | |||||||||||||||
| Official Title ICMJE | Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study). | |||||||||||||||
| 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. | |||||||||||||||
| Detailed Description |
Cleft margin flap (that was discarded in the modified Millard's technique for cleft lip repair) with anterior palatal closure will be used during primary cleft lip repair in patients who were born with cleft lip and palate in an attempt to close the Naso-alveolar fistula (defect) that usually occur and remain in those patients post-operatively and this will be assessed in the predetermined follow up period. Interventions: General operative procedures Eligible patients will be included in the study group:
After this, the dermis will be closed by using 6-0 vicryl sutures. Approximation of the vermilion cutaneous borders must be precise, as any misalignment will become accentuated with subsequent growth. 5-0 vicryl sutures placed in the vermillion and the mucosa of the lip completing the closure. Postoperative care:
All patients will be evaluated at the following intervals:
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| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase ICMJE | Not Applicable | |||||||||||||||
| Study Design ICMJE | Allocation: N/A 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
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| Condition ICMJE | Nasoalveolar Fistula (Defect) | |||||||||||||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE | Experimental: Cleft margin flap with anterior palatal closure
Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Intervention: Procedure: usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||||||||
| Estimated Enrollment ICMJE |
20 | |||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||
| Estimated Study Completion Date ICMJE | April 2020 | |||||||||||||||
| Estimated Primary Completion Date | April 2020 (Final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 2 Months to 6 Months (Child) | |||||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Egypt | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT03922438 | |||||||||||||||
| Other Study ID Numbers ICMJE | CEBD-CU-2019-04-12 | |||||||||||||||
| Has Data Monitoring Committee | Yes | |||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Dina Yacoub Girgis, Cairo University | |||||||||||||||
| Study Sponsor ICMJE | Cairo University | |||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||
| Investigators ICMJE |
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| PRS Account | Cairo University | |||||||||||||||
| Verification Date | November 2019 | |||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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