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Hard- and soft-tissue changes following the treatment of growing patients with skeletal class III malocclusion using the lower-clear-plate based intermaxillary traction versus the removable mandibular retractor: a two-arm randomized controlled trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND: Increased interest in intraoral devices like Bionator III, reverse twin block, and removable mandibular retractor (RMR), which modify tissues beneficially. The emerging Orthodontic Removable Traction Appliance (ORTA™) or the lower-clear-plate-based intermaxillary traction (LCP-IMT) has shown promising results, especially in stimulating maxillary growth and inhibiting mandibular growth in Class III malocclusion. OBJECTIVES: To evaluate the effectiveness of the LCP-IMT against the RMR during the early correction of Class III deformities in growing patients regarding skeletal, dental, and soft tissue variables. METHODS: A two-arm randomized controlled clinical trial was conducted from July 8, 2023, to June 15, 2024, at the Department of Orthodontics, University of Damascus. It enrolled patients aged 9 to 13 with mild to moderate skeletal Class III malocclusion (ANB + 1 to -3 degrees), an anterior crossbite involving two or more teeth, or an edge-to-edge relationship. Participants had normal or horizontal growth patterns (MM ≤ 35; SN.ManP ≤ 40) and lower incisor inclination (IMPA 85–100 degrees). Patients were randomly assigned to receive orthodontic treatment with either the LCP-IMT or the RMR appliance. Standardized lateral cephalometric images were collected before treatment (T1) and after active treatment (T2), using specialized orthodontic software (Viewbox). Soft- and hard-tissue changes in both groups were evaluated. Blinding was limited to data analysis due to feasibility constraints. RESULTS: The sample consisted of 30 patients (12 males and 18 females) (n = 15 for each group). All 30 patients were included in the analysis. Skeletal cephalometric analysis revealed no statistically significant differences between the LCP-IMT and RMR groups across all variables (P > 0.05), despite slightly greater SNA and ANB changes in the LCP-IMT group. Dentally, both groups showed favorable outcomes; however, the RMR group exhibited significantly greater lower incisor lingual inclination (L1.ManP: − 7.66° vs. − 5.05°, P = 0.016). Differences between the two groups in overjet, overbite, and soft tissue parameters—including upper lip protrusion and nasolabial angle did not reach statistical significance. CONCLUSIONS: Both appliances produced comparable short-term dental and soft-tissue improvements; a between-group difference in lower-incisor inclination favored LCP-IMT. These preliminary results require confirmation in larger and longer-term trials. TRIAL REGISTRATION: This study was retrospectively retrospectively registered in the Clinical Trials database (ID: NCT06596239) on the 11/09/2024. URL: https://clinicaltrials.gov/study/NCT06596239 .

Source: BMC Oral Health

DOI: 10.1186/s12903-025-07474-1

Authors: Mohammad N. Kheshfeh, Neriman Nassar, Mohammad Y. Hajeer, Ossama Aljabban, Mohammad Khursheed Alam

Institutions: Damascus University, University of Jordan, Jouf University

Language: English

Topic: Orthodontics and Dentofacial Orthopedics

Subfield: Orthodontics

Field: Dentistry

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,190