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

Primary Purpose

Nasoalveolar Fistula (Defect)

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasoalveolar Fistula (Defect) focused on measuring Cleft lip and palate, Cleft lip, Cleft alveolus, Cheiloplasty, Nasoalveolar fistula

Eligibility Criteria

2 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Oral and Dental Medicine- Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cleft margin flap with anterior palatal closure

Arm Description

Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.

Outcomes

Primary Outcome Measures

Naso-alveolar fistula
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2019
Last Updated
November 25, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03922438
Brief Title
Clinical Assessment of Usage of Cleft Margin Flap With Anterior Palatal Closure in Closure of Naso-alveolar Defect.
Official Title
Use of Cleft Margin Flap With Anterior Palatal Closure for Closure of Naso-alveolar Defect During Primary Cleft Lip Repair (Pilot Study).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: With the patient supine, general anesthesia will be induced, An uncuffed, oral, right angle endotracheal tube (RAE) will be placed and taped in the midline to the chin. The tube is further immobilized with a mouth pack. Head ring and shoulder rolls are placed. Sterile tapes will be placed over the closed eyelids. The face is prepared and draped. Reference points will be marked using brilliant green dye on a sharpened applicator stick. After careful marking, Approximately 3ml of 1% lidocaine with 1:200000 Epinephrines will be injected into the lip and alar base for homeostasis governed by heart rate of the patient. The lateral lip flap will first elevated with mucosal incision using number 15 blade scalpel at the gingivo-labial sulcus on the oral side and the release of the lateral lip segments will be achieved by dissecting over the lateral maxilla in the supra-periosteal plane. After this, a scalpel will be used to provide 1-2 mm of release of the skin from the underlying orbicularis oris muscle. This facilitates a 3 layer closure of mucosa, orbicularis oris muscle, and dermis. Then, the soft tissue attachments of the nasal base are separated from the piriform aperture. When the nasal dissection is complete, the surgeon is ready for closure of the lip deformity. Vomerine flap is done by doing incision on palatal side of the maxilla and vomer bone, then elevating mucoperiosteal flap on hard palate & undermining palatal mucosa. Closure of nasal lining. Mucosal flap obtained from part of the cleft near the lip was used as an inferior-based local flap. This flap was sutured to the anterior end of the mucoperiosteal flaps of the palate after it was passed from the alveolar cleft. The gingival mucosa on the alveolar cleft part was de-epithelialized, and lateral suturing of the flap was completed. In this way, not only the alveolar cleft but also the anterior palate cleft was corrected in this session. Skin hooks will be used to oppose the lip segments together to ensure that there is adequate release and minimal tension across the cleft wound. If too much tension exists, further dissection laterally or medially over the maxilla and superiorly along the bony piriform may be performed. Closure begins with 4-0 vicryl resorbable sutures placed in simple interrupted manner with the buried knots, to reconstituting the orbicularis oris muscular sphincter. 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: Cephalosporin antibiotic (Ceclor 125mg q12h) for five days. Otrivin saline nasal drops for 5 days. Mycostatin (Nystatin) Cream q8h for 5 days. Paracetamol drops 15ml. Fucidin cream ( sodium fusidate topical ) 3 times per day. Use of sterile tape as simple coverage for the wound for 5 days. Wash surgical wounds with soap & water until wound closes and heals. Massage the lip and columella with the cream downward with thumb once wound heals for 4-5 minutes twice a day for 3 months. All patients will be evaluated at the following intervals: One week following Surgery One month following Surgery Six months following Surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasoalveolar Fistula (Defect)
Keywords
Cleft lip and palate, Cleft lip, Cleft alveolus, Cheiloplasty, Nasoalveolar fistula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cleft margin flap with anterior palatal closure
Arm Type
Experimental
Arm Description
Usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Intervention Type
Procedure
Intervention Name(s)
usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.
Intervention Description
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 Measure Information:
Title
Naso-alveolar fistula
Description
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.
Time Frame
6 months postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Y Girgis, B.D.S
Phone
+201278061226
Email
dina.yacoub@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed G Beheiri, PhD
Organizational Affiliation
Faculty of Oral and Dental Medicine- Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mamdouh A AboulHassan, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled A Salah Eldein, PhD
Organizational Affiliation
Faculty of Oral and Dental Medicine- Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherif A Hassan, PhD
Organizational Affiliation
Faculty of Oral and Dental Medicine- Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dina Y Girgis, B.D.S
Organizational Affiliation
Faculty of Oral and Dental Medicine- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine- Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Y Girgis, B.D.S
Phone
+201278061226
Email
dina.yacoub@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mamdouh A AboulHassan, PhD
Phone
+201221022210
Email
aboulhassanm2@gmail.com
First Name & Middle Initial & Last Name & Degree
Dina Y Girgis, B.D.S

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11420018
Citation
Marcusson A, Akerlind I, Paulin G. Quality of life in adults with repaired complete cleft lip and palate. Cleft Palate Craniofac J. 2001 Jul;38(4):379-85. doi: 10.1597/1545-1569_2001_038_0379_qoliaw_2.0.co_2.
Results Reference
background
PubMed Identifier
17651127
Citation
Mossey P. Epidemiology underpinning research in the aetiology of orofacial clefts. Orthod Craniofac Res. 2007 Aug;10(3):114-20. doi: 10.1111/j.1601-6343.2007.00398.x.
Results Reference
background
PubMed Identifier
22759666
Citation
Mossey PA, Modell B. Epidemiology of oral clefts 2012: an international perspective. Front Oral Biol. 2012;16:1-18. doi: 10.1159/000337464. Epub 2012 Jun 25.
Results Reference
background
PubMed Identifier
19656316
Citation
Wehby GL, Cassell CH. The impact of orofacial clefts on quality of life and healthcare use and costs. Oral Dis. 2010 Jan;16(1):3-10. doi: 10.1111/j.1601-0825.2009.01588.x. Epub 2009 Jul 27.
Results Reference
background
PubMed Identifier
5220833
Citation
Wilhelmsen HR, Musgrave RH. Complications of cleft lip surgery. Cleft Palate J. 1966 Jul;3:223-31. No abstract available.
Results Reference
background
PubMed Identifier
27298546
Citation
Kuna SK, Srinath N, Naveen BS, Hasan K. Comparison of Outcome of Modified Millard's Incision and Delaire's Functional Method in Primary Repair of Unilateral Cleft Lip: A Prospective Study. J Maxillofac Oral Surg. 2016 Jun;15(2):221-8. doi: 10.1007/s12663-015-0816-z. Epub 2015 Jul 25.
Results Reference
background
PubMed Identifier
22075837
Citation
Isik D, Atik B, Tan O, Aktar S, Dogan M, Goktas U. Primary repair of the alveolar cleft. J Craniofac Surg. 2011 Nov;22(6):2224-6. doi: 10.1097/SCS.0b013e31823200c3.
Results Reference
background
PubMed Identifier
26491651
Citation
Park YW, Kwon KJ, Kim MK. Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue. Maxillofac Plast Reconstr Surg. 2015 Oct 13;37(1):35. doi: 10.1186/s40902-015-0035-z. eCollection 2015 Dec.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/11420018
Description
Quality of life in adults with repaired complete cleft lip and palate
URL
http://www.ncbi.nlm.nih.gov/pubmed/17651127
Description
Epidemiology underpinning research in the aetiology of orofacial clefts
URL
http://www.ncbi.nlm.nih.gov/pubmed/22759666
Description
Epidemiology of oral clefts 2012: an international perspective
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905869/
Description
The Impact of Orofacial Clefts on Quality of Life and Health Care Use and Costs
URL
http://www.ncbi.nlm.nih.gov/pubmed/5220833
Description
Complications of cleft lip surgery.
URL
http://www.ncbi.nlm.nih.gov/pubmed/22075837
Description
Primary repair of the alveolar cleft
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604496/
Description
Double-layered reconstruction of the nasal floor in complete cleft deformity of the primary palate using superfluous lip tissue

Learn more about this trial

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

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