Department of Oral and Maxillofacial Surgery, School of Dentistry and Dental Research Institute, Seoul National University, Seoul, South Korea; Department of Oral and Maxillofacial Surgery, Hallym University Sacred Heart Hospital, Anyang 14066, South Korea; Graduate School of Clinical Dentistry, Hallym University, Chuncheon 24252, South Korea; Institute of Clinical Dentistry, Hallym University, Chuncheon 24252, South Korea; Dental AI‑Robotics Center, Hallym University Sacred Heart Hospital, Anyang 14066, South Korea.
Department of Oral and Maxillofacial Surgery, Hallym University Sacred Heart Hospital, Anyang 14066, South Korea; Graduate School of Clinical Dentistry, Hallym University, Chuncheon 24252, South Korea; Institute of Clinical Dentistry, Hallym University, Chuncheon 24252, South Korea; Dental AI‑Robotics Center, Hallym University Sacred Heart Hospital, Anyang 14066, South Korea.
J Dent. 2024 Aug;147:105030. doi: 10.1016/j.jdent.2024.105030. Epub 2024 Apr 27.
Temporomandibular disorder (TMD) is a common condition that affects the temporomandibular joint (TMJ) and the muscles of the jaw, resulting in pain and dysfunction. TMD is affected by both behavioral and psychological factors. Digital therapeutics (DTx) can exert therapeutic effects by controlling behavioral factors through the delivery of appropriate interventions. Here, we report an open-label randomized control trial to evaluate the efficacy of DTx for TMD.
We recruited 40 participants diagnosed with TMD. Participants were randomly divided into an intervention group (DTx use, n = 20) and a control group (n = 20). The intervention group received the usual treatment process for TMD in addition to the use of the DTx. The control group received the usual treatments only. Patients in both groups were followed up for 3-4 weeks, and outcome data were collected and analyzed.
The intervention group showed a significant reduction in pain scores as measured by the numerical rating scale (NRS) (p = 0.016). Additionally, the intervention group showed a statistically significant increase in maximal mouth opening compared to the control group (p = 0.0079). However, there were no significant differences in improvement in the Jaw Functional Limitation Scale, Oral Behavior Checklist, and Patient Health Questionnaire-4 between the two groups (p = 0503, = 0.820, and = 0.943, respectively).
This RCT reveals DTx potential in TMD, showing pain and mouth opening improvements with conventional treatment. But no significant changes were noted in other outcomes. The findings advocate for more extensive, long-term research to solidify DTx's role in TMD management.
This research underlines DTx potential to improve pain outcomes in TMD therapy, reinforcing its value as a complementary treatment modality.
颞下颌关节紊乱（TMD）是一种常见的影响颞下颌关节（TMJ）和颌部肌肉的疾病，导致疼痛和功能障碍。TMD 受行为和心理因素的影响。数字疗法（DTx）可以通过提供适当的干预措施来控制行为因素，从而发挥治疗作用。在这里，我们报告了一项开放标签随机对照试验，以评估 DTx 治疗 TMD 的疗效。
我们招募了 40 名被诊断为 TMD 的参与者。参与者被随机分为干预组（DTx 使用，n = 20）和对照组（n = 20）。干预组在接受 TMD 常规治疗过程的基础上，还使用了 DTx。对照组仅接受常规治疗。两组患者均随访 3-4 周，收集和分析结果数据。
干预组的数字评分量表（NRS）疼痛评分显著降低（p = 0.016）。此外，与对照组相比，干预组的最大张口度有统计学显著增加（p = 0.0079）。然而，两组间在 Jaw Functional Limitation Scale、Oral Behavior Checklist 和 Patient Health Questionnaire-4 的改善方面无显著差异（p = 0.503、= 0.820 和 = 0.943）。
这项 RCT 揭示了 DTx 在 TMD 中的潜力，表明其与常规治疗相结合可改善疼痛和张口度。但其他结果无显著变化。研究结果主张进行更广泛、长期的研究，以确定 DTx 在 TMD 管理中的作用。
本研究强调了 DTx 在 TMD 治疗中改善疼痛结局的潜力，强化了其作为一种补充治疗方式的价值。
