Evidence map›Paper›PMID 41350990›Full record

Trial reportBMC oral health2025

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.

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

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06596239 (Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT06596239 nacompletednot on this map

Hard- and Soft-tissue Changes Following Class III Treatment With the Lower-Clear-Plate-Based Intermaxillary Traction Versus the Removable Mandibular Retractor: a Two-arm Randomized Controlled Clinical Trial

TypeinterventionalSponsorDamascus UniversityRan2023 to 2024Enrolled30ConditionsClass III MalocclusionArmslower-clear-plate-based intermaxillary traction (LCP-IMT), Removable mandibular retractor (RMR)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Mohammad N KheshfehDepartment of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus, Syria.
Neriman NassarDepartment of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus, Syria.
Mohammad Y HajeerDepartment of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus, Syria. myhajeer@gmail.com.
Ossama AljabbanDepartment of Restorative Dentistry and Endodontics, Faculty of Dentistry, Damascus University, Damascus, Syria.
Mohammad Khursheed AlamOrthodontic Division, Preventive Dentistry Department, College of Dentistry, Jouf University, Sakaka, 72345, Saudi Arabia.

Funding

Damascus University 501100020595
6 · The paper itself

Abstract

backgroundIncreased 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.

objectivesTo 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.

methodsA 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.

resultsThe 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.

conclusionsBoth 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 registrationThis study was retrospectively retrospectively registered in the Clinical Trials database (ID: NCT06596239) on the 11/09/2024. URL: https://clinicaltrials.gov/study/NCT06596239 .

Indexed as

Extraoral Traction AppliancesMalocclusion, Angle Class IIIMandibleOrthodontic Appliances, RemovableAdolescentCephalometryChildFemaleHumansIncisorMaleMaxillaMaxillofacial DevelopmentOrthodontic Appliance DesignTreatment OutcomeAnterior crossbiteDental changesSkeletal changesSkeletal class IIISoft tissue changes

Identifiers

PMID41350990
PMCPMC12797752

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.