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单侧唇裂修复术中使用定制鼻整形器后对称性及家长满意度评估:一项随机对照临床试验

Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial.

作者信息

Khodir Mahmoud Akram, Osman Saeeda Mahmoud, Ragab Hala Ragaa, AboulHassan Mamdouh Ahmed, Oraby Mona Samy

机构信息

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Alexandria University, Champlion Street, El-Azarita, Alexandria, Egypt.

Department of General Surgery, Plastic Section, Faculty of Medicine, Cairo University, Al-Saray Street, Al-Manial, Cairo, Egypt.

出版信息

Head Face Med. 2025 Aug 1;21(1):55. doi: 10.1186/s13005-025-00533-6.

DOI:10.1186/s13005-025-00533-6
PMID:40751267
Abstract

OBJECTIVES

To evaluate the effectiveness of customized nasal conformers used after unilateral cleft lip repair on nasal symmetry and parental satisfaction.

MATERIALS AND METHODS

Fourteen medically free, non-syndromic children aged 10-24 weeks with unilateral cleft lip were divided into two groups. All patients underwent primary repair using the Fisher technique. Group I received customized nasal conformers fabricated using digital models, while Group II did not. Anthropometric measurements, including nostril height and width, columella deviation angle, and nasolabial angle were used to assess nasal symmetry between both groups. Parental satisfaction was evaluated using the Cleft Evaluation Profile (CEP).

RESULTS

At six months postoperatively, Group I showed no significant difference between cleft and non-cleft sides across all parameters. In contrast, Group II exhibited significant asymmetry in nostril height and width, although no significant difference was observed in the nasolabial angle. CEP scores showed significantly higher satisfaction in fathers for lip, nose, and profile, and in mothers for nose and profile. No significant difference was noted in teeth appearance for either parent group. Intra-examiner reliability was reliable across all parameters.

CONCLUSIONS

The use of customized postsurgical nasal conformers in unilateral cleft lip repair was associated with improved symmetry between cleft and non-cleft sides and appeared to reduce relapse, which may have contributed to increased parental satisfaction with the treatment.

TRIAL REGISTRATION

Was retrospectively registered at Clinicaltrials.gov on 23/10/2024 (NCT06637488).

摘要

目的

评估单侧唇裂修复术后使用定制鼻整形器对鼻对称性及家长满意度的效果。

材料与方法

将14名年龄在10 - 24周、无综合征、医疗条件良好的单侧唇裂患儿分为两组。所有患者均采用费舍尔技术进行一期修复。第一组使用根据数字模型制作的定制鼻整形器,第二组未使用。通过人体测量,包括鼻孔高度和宽度、鼻小柱偏斜角度和鼻唇角,来评估两组之间的鼻对称性。使用唇裂评估量表(CEP)评估家长满意度。

结果

术后6个月,第一组在所有参数上患侧与非患侧之间均无显著差异。相比之下,第二组在鼻孔高度和宽度上表现出显著不对称,尽管在鼻唇角上未观察到显著差异。CEP评分显示,父亲对唇部、鼻部和侧面轮廓的满意度显著更高,母亲对鼻部和侧面轮廓的满意度显著更高。两组家长对牙齿外观的评价均无显著差异。所有参数的检查者内信度均可靠。

结论

在单侧唇裂修复术中使用定制的术后鼻整形器与患侧和非患侧之间对称性的改善相关,且似乎减少了复发,这可能有助于提高家长对治疗的满意度。

试验注册

于2024年10月23日在Clinicaltrials.gov进行回顾性注册(NCT06637488)。

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本文引用的文献

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The Global Occurrences of Cleft Lip and Palate in Pediatric Patients and Their Association with Demographic Factors: A Narrative Review.小儿患者唇腭裂的全球发病率及其与人口统计学因素的关联:一项叙述性综述
Children (Basel). 2024 Mar 8;11(3):322. doi: 10.3390/children11030322.
2
Utilization of images and three-dimensional custom-made nostril retainer fabricate for patients with cleft lip and cleft lip nose deformities at Siriraj Hospital: preliminary phase.利用图像和三维定制鼻孔保持器为 Siriraj 医院唇裂和唇裂鼻畸形患者进行制作:初步阶段。
Sci Rep. 2023 Nov 4;13(1):19109. doi: 10.1038/s41598-023-46327-1.
3
The Role of Postoperative Nasal Stents in Cleft Rhinoplasty: A Systematic Review.
术后鼻腔支架在唇腭裂鼻整形术中的作用:系统评价。
Cleft Palate Craniofac J. 2024 Dec;61(12):1941-1950. doi: 10.1177/10556656231190703. Epub 2023 Jul 28.
4
The Rule of 10s for Cleft Repair: A Historical Review of the Literature.《裂隙修复的 10 法则:文献回顾》
J Craniofac Surg. 2023 May 1;34(3):884-887. doi: 10.1097/SCS.0000000000008994. Epub 2022 Sep 6.
5
Short-term surgical outcomes in patients with unilateral complete cleft lip and palate after presurgical nasoalveolar molding therapy: A three-dimensional anthropometric study.术前鼻牙槽塑形治疗后单侧完全性唇腭裂患者的短期手术结局:一项三维人体测量学研究
Front Pediatr. 2022 Dec 30;10:1101184. doi: 10.3389/fped.2022.1101184. eCollection 2022.
6
Efficacy of Postsurgical Nostril Retainer in Patients with Unilateral Cleft Lip and Palate Treated with Presurgical Nasoalveolar Molding and Primary Cheiloplasty-Rhinoplasty.术前鼻牙槽塑形和唇裂修复术联合治疗单侧唇裂腭裂患者术后鼻瓣复位器的疗效。
Plast Reconstr Surg. 2022 Sep 1;150(3):623-629. doi: 10.1097/PRS.0000000000009426. Epub 2022 Jul 1.
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Effectiveness of the Nasal Creator Device after Cheiloplasty in Patients with Cleft Lip and Palate as Measured by 3D Stereophotogrammetry.腭裂修复术后应用鼻腔扩张器对唇腭裂患者的疗效评估:三维体视摄影术测量
J Clin Pediatr Dent. 2021 Oct 1;45(4):284-290. doi: 10.17796/1053-4625-45.4.12.
8
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Accuracy of CAD/CAM-fabricated bite splints: milling vs 3D printing.CAD/CAM 制作的咬合垫的准确性:铣削与 3D 打印。
Clin Oral Investig. 2020 Dec;24(12):4607-4615. doi: 10.1007/s00784-020-03329-x. Epub 2020 May 21.
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Mymensingh Med J. 2019 Oct;28(4):833-838.