Assessing the clinical accuracy of low level Lesar therapy in skeletal calss II patents undergoing myofunctional appliance therapy with-versus without extraoral condyle locating device and further evaluating the comparative clinical efficacy of said two therapy approaches: a randomised controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
This two phase study aims to develop validate and clinically evaluate a newly designed Extraoral Condyle Locating Device EOCLD for precise targeting of low level laser therapy LLLT during myofunctional appliance treatment in skeletal Class II patients Phase I involves fabrication of the EOCLD followed by assessment of its clinical accuracy and reliability in localizing the mandibular condyle using radiographic confirmation as the reference standard Phase II is a randomized controlled trial comparing the efficacy of EOCLD guided LLLT versus conventional non guided LLLT when used with myofunctional appliance therapy Primary outcomes include condylar growth and adaptive remodeling assessed through 3D radiographic measurements The study aims to determine whether anatomically guided LLLT improves treatment precision and enhances mandibular growth modifications compared to standard laser application
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Day(s) 至 35.00 Day(s)(—)
- 性别
- All
入选标准
- •Age group: 10–35 years • No prior orthodontic or orthopedic treatment • Normal TMJ function and absence of pain or clicking.
排除标准
- •Exclusion criteria • Patients with craniofacial syndromes, cleft lip/palate, or any congenital facial deformities.
- •• History of previous orthodontic or orthopedic treatment.
- •• Presence of systemic diseases (e.g., growth hormone disorders, juvenile arthritis) affecting growth.
- •• Temporomandibular joint (TMJ) disorders, pain, or restricted mouth opening at baseline • Patients with poor oral hygiene, active dental caries, or periodontal disease.
- •• Uncooperative behaviour or inability to follow study protocols.
- •• Contraindications to LLLT, such as photosensitivity, epilepsy, or ongoing medication affecting bone metabolism.
- •• Inability or refusal to undergo CBCT imaging.
- •• Patients with metal allergies or hypersensitivity to appliance materials.
研究者
DR SHILPA M KENDRE
Sharad Pawar Dental College and Hospital Sawangi Wardha
