Trial reportBMC oral health2026
Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial.
Trial report in BMC oral health, 2026. 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.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProper nasal repair and relapse prevention remain key challenges in complete cleft lip patients. This study aimed to assess the effectiveness of customized nasal conformers, designed through an easy and reproducible method, in improving nasal symmetry. MATERIALS AND
methodsFourteen patients were enrolled in a pilot randomized controlled clinical trial divided equally into study and control groups. All underwent Fisher anatomic subunit repair. In the study group, a customized nasal conformer was digitally fabricated, applied on the day of surgery, and sutured in place for 3 months. No conformer was used in the control group. Digital anthropometric measurements were performed at 6 months postoperatively, including alar width, alar base width, columella length, nasal tip projection, columellar angle, and nostril height/width ratio. Statistical analyses were performed for both within-group and between-group comparisons and parental satisfaction was assessed using a 10-point visual analogue scale (p < 0.05).
resultsThe study group showed no significant change in most parameters. The control group showed significant changes in all parameters except nasal tip projection. Symmetry correlation was significantly better in the study group. Between-group analysis showed significantly less deviation in the study group for all parameters except nasal tip projection and columella angle. Comparison of visual analogue scale between 2 groups showed statistically significant difference.
conclusionsCustomized nasal conformers, when employed in unilateral cleft lip repair, showed promising potential in reducing relapse, improving nasal symmetry, refining nasolabial esthetics, and enhancing parental satisfaction.
trial registrationThe trial was retrospectively registered (NCT06637488) on 1st of October 2024 at ClinicalTrials.gov.
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