Evaluation of the Efficacy of Functional Therapy Using Modified Twin Block Versus Clear Twin Block in Class II Skeletal Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the effectiveness of a modified Twin Block appliance compared to a conventional clear Twin Block appliance in the treatment of skeletal Class II malocclusion caused by mandibular retrusion in growing patients.
This is a two-arm randomized controlled clinical trial including patients aged 10-13 years diagnosed with skeletal Class II malocclusion. Participants will be randomly allocated into two equal groups.
Skeletal, dental, and soft tissue changes will be assessed using lateral cephalometric analysis and cone-beam computed tomography (CBCT). Additionally, temporomandibular joint (TMJ) health, pain perception, and functional tolerance will be evaluated using standardized clinical indices and patient-reported outcome measures.
The study aims to compare the modified appliance with the conventional design in terms of skeletal improvement, TMJ safety, and patient acceptance.
详细描述
Skeletal and dentofacial anomalies, particularly Class II malocclusion due to mandibular retrusion, represent one of the most prevalent orthodontic problems during growth. Functional appliances, especially the Twin Block appliance, are widely used to enhance mandibular development and correct jaw discrepancies. However, variations in treatment protocols, particularly regarding advancement mechanics and appliance modifications, may influence both skeletal outcomes and temporomandibular joint (TMJ) response.
This study aims to investigate the effects of a modified Twin Block appliance, incorporating progressive mandibular advancement and additional design modifications such as lower lip pads intended to influence muscular activity, compared to a conventional clear Twin Block appliance.
A two-arm randomized controlled trial will be conducted on growing patients aged 10-13 years diagnosed with skeletal Class II malocclusion due to mandibular retrusion. Participants will be randomly allocated into two equal groups using a computer-generated randomization sequence with allocation concealment.
Skeletal and dental changes will be evaluated using lateral cephalometric radiographs and cone-beam computed tomography (CBCT), with particular attention to condylar morphology, joint space dimensions, and craniofacial skeletal relationships. TMJ health will be assessed using the Helkimo Index. Patient comfort, pain perception, and functional adaptation will be evaluated using validated questionnaires administered at multiple time points throughout the treatment period.
Radiographic and clinical assessments will be performed at baseline (T0) and after 7 months of functional appliance therapy (T1). Repeated patient-reported outcome measures will be collected at predefined intervals during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients.
- •Patients willing to accept removable functional appliance therapy.
- •Skeletal Class II malocclusion (Angle Class II Division 1).
- •Skeletal Class II due to mandibular retrusion (ANB ≥ 5°, 6 mm ≤ OJ ≤ 13 mm , SNB ≤ 78°, with normal maxillary position).
- •Growth stage corresponding to MP3 stage or pre-pubertal peak according to hand-wrist radiograph (Björk and Helm, 1967).
- •No severe dental crowding in the dental arches and no significant maxillary dental protrusion.
- •Absence of congenital anomalies, trauma, burns, or surgical scars affecting the temporomandibular joint or craniofacial structures.
- •Absence of systemic or rheumatologic diseases affecting the temporomandibular joint.
排除标准
- •Presence of clinical signs or symptoms of temporomandibular joint disorders.
- •Functional mandibular deviation.
- •Previous orthodontic treatment.
研究组 & 干预措施
Modified Twin Block Group
Patients in this group will be treated using a modified Twin Block appliance incorporating progressive mandibular advancement and lower lip pads designed to influence muscular activity and enhance skeletal effects.
干预措施: Modified Twin Block Appliance (Device)
Conventional Clear Twin Block Group
Patients in this group will be treated using a conventional clear Twin Block functional appliance for correction of skeletal Class II malocclusion.
干预措施: Conventional Clear Twin Block Appliance (Device)
研究者
Feras baba
Associate Professor
University of Aleppo