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The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side .
Participants will receive nasal conformers intraoperative with follow up of 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral cleft lip repair using customized nasal conformer | Experimental |
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| Unilateral cleft lip repair without using customized nasal conformer | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cleft lip repair using fisher technique | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nostril height | The greatest vertical distance of the nostril in millimeters . | 6 months |
| Nostril width | This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters. | 6 months |
| Columellar Deviation Angle | The midline columellar deviation from the vertical reference line was measured in degrees. | 6 months |
| Nasolabial Groove Angle | To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of dentistry, Alexandria university | Alexandria | 21715 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41987134 | Derived | Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial. BMC Oral Health. 2026 Apr 15;26(1):735. doi: 10.1186/s12903-026-08274-x. | |
| 40751267 | Derived | 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. |
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| cleft lip repair using fisher technique | Procedure | 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 |
|