Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 2, 2026
Date Accepted: Jun 4, 2026
Development and Validation of an Extraoral Condyle Locating Device and Its Impact on Low-Level Laser Therapy in Skeletal Class II Patients: Protocol for a Two-Phase Randomized Controlled Trial
ABSTRACT
Background:
Precise localization of the mandibular condyle is essential for extraoral therapeutic procedures such as low-level laser therapy (LLLT) in skeletal Class II patients undergoing myofunctional appliance therapy. Conventional localization methods rely on palpation and visual estimation, which are operator-dependent and may compromise reproducibility and treatment outcomes. To address this limitation, a spectacle-mounted Extraoral Condyle Locating Device (EOCLD) has been developed to facilitate accurate and consistent condylar targeting.
Objective:
To develop and validate the EOCLD for precise condylar localization and to evaluate its impact on the clinical efficacy of LLLT in skeletal Class II patients undergoing myofunctional appliance therapy.
Methods:
This two-phase study will be conducted in growing skeletal Class II patients. In Phase I, the EOCLD will be evaluated for accuracy and reproducibility through radiographic comparison with CBCT imaging. In Phase II, a prospective randomized controlled trial will be undertaken in which participants receiving myofunctional appliance therapy will be randomly allocated to EOCLD-guided LLLT or conventional unguided LLLT. Skeletal and dentoalveolar changes will be assessed using standardized cephalometric analyses, along with evaluation of treatment duration and patient-reported comfort.
Results:
This manuscript describes the study protocol. Data collection and analysis will be completed after the study period.
Conclusions:
This study will establish the clinical validity of the EOCLD and determine whether guided LLLT enhances treatment efficiency and skeletal outcomes in skeletal Class II therapy. Key words: Extraoral Condyle Locating Device (EOCLD); Low-Level Laser Therapy (LLLT); Skeletal Class II; Myofunctional Appliance Therapy; Condylar Growth; Cone-Beam Computed Tomography (CBCT); Functional Orthopedics; Randomized Controlled Trial; Condylar Localization; Laser-Assisted Orthodontics. CTRI reg.no- CTRI/2026/02/102982
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