Trial reportHead & face medicine2025
Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial.
Trial report in Head & face medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06637488 (Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the effectiveness of customized nasal conformers used after unilateral cleft lip repair on nasal symmetry and parental satisfaction. MATERIALS AND
methodsFourteen 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).
resultsAt 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.
conclusionsThe 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 registrationWas retrospectively registered at Clinicaltrials.gov on 23/10/2024 (NCT06637488).
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