Structured Telemonitoring as an Adjunct to Conservative Management of Temporomandibular Disorder-Related Orofacial Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum pain-free mouth opening (mm)
研究概览
简要总结
This prospective randomized clinical trial evaluates the effectiveness of a structured telemonitoring protocol as an adjunct to conservative management in patients with temporomandibular disorder (TMD)-related orofacial pain. Participants receive standardized conservative therapy based on behavioural counselling, habit reversal training, and home-based self-management exercises, with or without structured telemonitoring. Clinical outcomes include pain intensity, mandibular function, and oral behaviours, assessed over a 9-month follow-up period. The study aims to determine whether telemonitoring improves treatment adherence, behavioural modification, and clinical outcomes compared with conventional in-office follow-up.
详细描述
This prospective randomized clinical trial evaluates the effectiveness of a structured telemonitoring protocol as an adjunct to conservative management in patients with temporomandibular disorder (TMD)-related orofacial pain. Participants receive standardized conservative therapy based on behavioural counselling, habit reversal training, and home-based self-management exercises, with or without structured telemonitoring. Clinical outcomes include pain intensity, mandibular function, and oral behaviours, assessed over a 9-month follow-up period. The study aims to determine whether telemonitoring improves treatment adherence, behavioural modification, and clinical outcomes compared with conventional in-office follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years.
- •Diagnosis of temporomandibular disorder (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- •Presence of chronic orofacial pain persisting for more than 30 days.
- •Diagnosis of myofascial pain involving the masticatory muscles, with or without headache attributed to TMD.
- •Ability to use a mobile device compatible with telemonitoring procedures.
排除标准
- •Systemic diseases affecting pain perception or neuromuscular function (including autoimmune, neurological, or neoplastic disorders).
- •History of severe orofacial trauma.
- •Previous major temporomandibular joint surgery.
- •Ongoing orthodontic treatment.
- •Current use of occlusal splints.
- •Current use of muscle relaxants or psychoactive medications.
研究组 & 干预措施
Telemonitoring group (TG)
The TG received an active management protocol consisting of standard myofascial therapy combined with monthly in-office clinical evaluations and weekly structured remote interactions.
干预措施: Structured Telemonitoring (Behavioral)
Control group (CG)
CG received conventional care based on monthly in-office clinical follow-up and standard therapeutic instructions without any form of remote monitoring.
干预措施: Conservative Management (Behavioral)
结局指标
主要结局
Maximum pain-free mouth opening (mm)
时间窗: Baseline (T0), 3 months (T1), and 9 months (T2)
Change in maximum pain-free mouth opening measured in millimetres (mm) as an indicator of mandibular functional improvement.
Mandibular lateral excursions (mm)
时间窗: Baseline (T0), 3 months (T1), and 9 months (T2)
Change in right and left mandibular lateral excursion measured in millimetres (mm).
Protrusive movement (mm)
时间窗: Baseline (T0), 3 months (T1), and 9 months (T2)
Change in maximum mandibular protrusive movement measured in millimetres (mm).
Pain intensity assessed using the Visual Analogue Scale (VAS)
时间窗: Baseline (T0), 3 months (T1), and 9 months (T2)
Change in perceived pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where higher scores indicate greater pain intensity. Scale range is 0 to 10.
次要结局
- Oral Behaviours Checklist (OBC) score(Baseline (T0), 3 months (T1), and 9 months (T2))
研究者
Amerigo Giudice
Professor
University Magna Graecia