Evaluating the Impact of Occlusal Splint Therapy on Upper Airway Dimensions and Mandibular Condylar Position in Myofascial Pain Patients with Average Skeletal Growth Patterns: A CBCT-based Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Changes in Upper Airway Dimensions measured via CBCT
研究概览
简要总结
This randomized control trial aims to evaluate theimpact of occlusal splint therapy on upper airway dimensions and mandibularcondylar position in patients with myogenic temporomandibular joint disorders(TMJD) using Cone Beam Computed Tomography (CBCT). Participants will be dividedinto three groups: Group 1 (intervention) will receive both occlusal splinttherapy and pharmacotherapy, Group 2 will receive pharmacotherapy alone, andGroup 3 will serve as healthy controls without TMJD. The intervention includesa custom-fitted maxillary occlusal splint made of transparent acrylic resindesigned to promote mandibular repositioning and alleviate myogenic pain.Pharmacotherapy consists of NSAIDs and muscle relaxants (BID for 5 days and asneeded). Pre-treatment CBCT scans will be conducted for all participants,followed by post-treatment scans after 3 months for Groups 1 and 2. PrimaryOutcome Measures will be the changes in Upper Airway Dimensions and MandibularCondylar Position assessed using CBCT, including airway volume, cross-sectionalarea, airway length, joint space measurements, and condylar positioning. SecondaryOutcome Measures will be the comparative analysis of airway and condylar changesacross groups, Correlation between airway dimensions and condylar position., Symptomimprovement through pain reduction and enhanced jaw mobility, Evaluation of theoverall effectiveness of occlusal splint therapy. The results from this studywill provide valuable insights into the therapeutic benefits of occlusal splinttherapy for myogenic TMJD patients, potentially contributing to improvedtreatment protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Range: 20-30 years.
- •Diagnosis: Myogenic temporomandibular disorders (TMD), specifically myofascial pain.
- •Skeletal Growth Pattern: Average skeletal growth pattern (determined by composite cephalometric analysis).
- •Consent: Written informed consent provided.
- •No Prior TMJ Treatment: No previous temporomandibular joint or occlusal therapy.
排除标准
- •Systemic Diseases: Conditions affecting TMJ or airway (e.g., rheumatoid arthritis, sleep apnea).
- •Craniofacial Anomalies: Cleft palate, craniosynostosis, etc.
- •Previous Orthodontic/Surgical Treatment: Orthodontic or craniofacial surgery.
- •Pregnancy: Excluded due to hormonal influences and CBCT radiation.
- •Respiratory Conditions: Asthma, COPD, chronic rhinitis, etc.
- •Psychiatric Disorders: Conditions affecting compliance (e.g., schizophrenia, major depression).
- •TMJ Degenerative Diseases: Osteoarthritis, ankylosis, etc.
- •Malocclusion/Skeletal Discrepancies: Class II, Class III, severe open bite.
- •Medication Use: Medications affecting muscle or TMJ function (e.g., corticosteroids).
结局指标
主要结局
1.Changes in Upper Airway Dimensions measured via CBCT
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
Total Airway Volume: From nasopharynx to hypopharynx, measured in mm³, Segmental Airway Volumes: Nasopharyngeal Volume in mm³. Oropharyngeal Volume in mm³. Hypopharyngeal Volume in mm³ Minimum Cross-Sectional Area : Smallest area within the airway, measured in mm²
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
Airway Length: Distance from the nasopharynx to the hypopharynx, measured in mm
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
Presence of Obstructions or Anomalies: Identification of any airway obstructions (e.g., adenoids, hypertrophy).
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
2.Changes in Mandibular Condylar Position measured via CBCT
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
Joint Space Measurements, Condylar Ratio, Angular and Morphological Parameters: Sagittal Condylar Guidance Angle
时间窗: Baseline: Before initiation of the intervention | 3 Months: Final assessment using CBCT
次要结局
- 1.Comparison Between Groups:(Differences in upper airway dimensions and mandibular condylar position across all groups:)