Trial reportBMC oral health2026
Efficacy of skeletally anchored modified leaf expander versus modified conventional Hyrax in maxillary molar distalization: a randomized clinical 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 NCT06308640 (Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography), which is not on this map. Cited by 1 paper.
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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
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Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography
Who cites it
1 citing paper in PubMed.
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDistalization in orthodontics is one of conservative treatment modalities that result in gaining space especially in dental orthodontic cases of class ΙΙ molar relationship.
aimA prospective parallel double group randomized clinical trial aimed to compare the distalization effects of the skeletally anchored modified Leaf Expander versus the skeletally anchored modified conventional Hyrax Expander. Skeletally anchored distalizers for orthodontic treatment are better than dentally anchored distalizers (Superiority). PATIENTS AND
methodsThirty patients (15-18 years) who were requiring maxillary molar distalization, were randomly allocated into two groups (n = 15 each). Group 1 received the modified skeletally anchored self-activated Leaf Expander, and Group 2 received the modified skeletally anchored conventional Hyrax Expander. Pre- and post-distalization lateral cephalometric radiographs and digital dental models were analyzed for skeletal, dental, and arch dimensional changes. The primary outcomes of the current study were: Arch length, Inter-canine width, Inter-first premolar width, Inter-second premolar width and Inter-first molar width, all these parameters were assessed after completion of distalization and result in class 1 molar relationship. Treatment duration and adverse events were also recorded. Statistical analysis included paired t-tests and independent t-tests, with Bonferroni correction (α = 0.0045) applied for multiple comparisons. Effect sizes (Cohen's d) were calculated to assess clinical relevance.
resultsBoth appliances achieved significant distalization of maxillary first molars as assessed on lateral cephalometric analysis (Leaf: -7.65 ± 0.74 mm(95% CI: -8.06 - -7.24); Hyrax: -6.95 ± 0.82 mm(95% CI: -7.41 - -6.49) with effect size (d) 0.87) with minimal angular changes. Treatment duration was significantly shorter for the Hyrax group (6.52 ± 1.52 months (95% CI: 6.02-7.54)) compared to the Leaf group (10.43 ± 1.52 months (95% CI: 9.94-11.46); p < 0.001, effect size (d) = 2.35). Skeletal parameters (SNA, SNB, ANB, FH-MP), incisor inclinations (U1/PP, L1/MP), overjet, and arch dimensions showed no statistically significant differences after Bonferroni correction, though some differences were clinically relevant. Mild gingival enlargement occurred in three patients, managed conservatively.
conclusionBoth appliances effectively achieved significant distalization of maxillary molars; however, the modified skeletally anchored conventional Hyrax Expander achieved distalization faster than the modified skeletally anchored Leaf Expander.
trial registrationClinicalTrials.gov Identifier: NCT06308640. Retrospectively registered on 29 February 2024. (first enrolment).
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