Effectiveness of a PhysiOsteopathic Program to Prevent Temporomandibular and Cervicofacial Pain After Dental Procedures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome will be the incidence of clinically significant temporomandibular disorder (TMD) at 3 months following the dental procedure. Clinically significant TMD will be defined as meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for pain or dysfunction, accompanied by either a Numeric Rating Scale (NRS) pain score of 3 or higher (on a 0–10 scale) or a Jaw Functional Limitation Scale (JFLS) score of at least 10 points.
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a combined physiotherapy and osteopathy program in preventing temporomandibular joint and cervicofacial pain and dysfunction following dental procedures that require prolonged mouth opening. The study is based on the hypothesis that sustained stretching and loading of the temporomandibular joint and associated muscles during dental treatment can lead to nociceptive sensitization in the trigeminal system, resulting in pain and movement limitations in the jaw and cervical region. Participants aged 18 to 60 years undergoing dental procedures lasting 30 minutes or more will be randomly assigned to one of three groups: conventional splint therapy, cranio cervical physiotherapy and osteopathy, or an integrated combined therapy program. Outcomes will include pain scores, jaw and neck function, quality of life measures, and adverse events assessed over a three-month follow-up period. The primary goal is to determine whether the integrated combined therapy approach is more effective than standard care in preventing the onset of temporomandibular disorders and cervical dysfunction after dental procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be adults aged 18 to 60 years who are scheduled to undergo dental procedures requiring at least 30 minutes of continuous mouth opening.
- •Eligible participants must have no severe or active temporomandibular disorders (TMD) at baseline, as determined by the DC/TMD diagnostic criteria.
- •They must be willing and able to attend physiotherapy sessions following their dental procedure.
排除标准
- •Participants will be excluded if they have a history of temporomandibular joint (TMJ) surgery or craniofacial trauma, systemic inflammatory disorders such as rheumatoid arthritis or fibromyalgia, or if they are currently undergoing physiotherapy for TMD or neck pain.
- •Individuals with cognitive or physical impairments that would limit their ability to participate in the study will also be excluded.
结局指标
主要结局
The primary outcome will be the incidence of clinically significant temporomandibular disorder (TMD) at 3 months following the dental procedure. Clinically significant TMD will be defined as meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for pain or dysfunction, accompanied by either a Numeric Rating Scale (NRS) pain score of 3 or higher (on a 0–10 scale) or a Jaw Functional Limitation Scale (JFLS) score of at least 10 points.
时间窗: At baseline,1 week, 4 weeks and 8 weeks
次要结局
- The study will assess pain trajectory in the jaw, face, & neck, using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS). Maximum mouth opening (interincisal distance) & the Jaw Functional Limitation Scale (JFLS-20) will be used to evaluate jaw function, while the Neck Disability Index (NDI) will measure cervical function. Quality of life will be assessed with the Oral Health Impact Profile (OHIP-14) or EQ-5D. Additional parameters include muscle tenderness & trigger point scores, analgesic or rescue medication use, & documentation of any adverse events(At baseline, 1 week, 4 weeks, & 8 weeks)
研究者
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences