Using Customized Nasal Conformer in Correction of Cleft Nasal Deformity in Patients with Unilateral Cleft Lip
NCT ID: NCT06637488
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2024-01-01
2024-09-01
Brief Summary
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* Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle.
* Evaluation of degree of similarity using esthetic scales at six months postoperative.
Participants will receive nasal conformers intraoperative with follow up of 6 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unilateral cleft lip repair using customized nasal conformer
cleft lip repair using fisher technique
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side
Unilateral cleft lip repair without using customized nasal conformer
cleft lip repair using fisher technique
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. No nasal conformers used in this group
Interventions
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cleft lip repair using fisher technique
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side
cleft lip repair using fisher technique
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. No nasal conformers used in this group
Eligibility Criteria
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Inclusion Criteria
2. Age range 10 - 24 weeks.
3. Hemoglobin more than 10 gm/dl .
4. Weight more than 10 lbs.
Exclusion Criteria
2. Patients with conditions contradicting operation.
3. Patients with Bilateral cleft lip.
4. Patients with previous surgeries in lip and nose.
10 Weeks
24 Weeks
ALL
No
Sponsors
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Mahmoud Akram
OTHER
Responsible Party
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Mahmoud Akram
Assistant lecturer of Oral and Maxillofacial surgery
Locations
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faculty of dentistry, Alexandria university
Alexandria, , Egypt
Countries
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References
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Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial. Head Face Med. 2025 Aug 1;21(1):55. doi: 10.1186/s13005-025-00533-6.
Other Identifiers
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Nasal conformer in cleft lip
Identifier Type: -
Identifier Source: org_study_id
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