Background: Temporomandibular disorders (TMDs) are common chronic musculoskeletal conditions associated with pain, jaw dysfunction, and impaired quality of life and influenced by behavioral and psychological factors. Digital therapeutics (DTx) may improve access to standardized behavioral interventions, but their clinical efficacy for TMD has not been adequately established. Objective: This study aimed to investigate the efficacy of a mobile-based DTx intervention (Clickless DTx TMD-01) compared with a sham app in reducing pain and improving functional and psychological outcomes in patients with TMD. Methods: We conducted a multicenter, double-blind, randomized, sham-controlled trial at 2 university hospitals in South Korea. Adults aged between 19 and 65 years with a diagnosis of TMD according to the diagnostic criteria for TMD were randomly assigned (1:1) to the intervention group or sham control. The intervention was delivered via the DTx mobile app and included TMD-related disease education, guided jaw exercises, behavioral habit tracking, psychoeducational content, guided meditation, and data-driven feedback. The sham app provided only symptom recording without therapeutic content. Participants were instructed to use the assigned app daily for 6 weeks. The primary outcome was change in pain intensity measured by a 100-mm visual analog scale. Secondary outcomes included maximum mouth opening and scores on the Jaw Functional Limitation Scale-20, Oral Behaviors Checklist, and Patient Health Questionnaire-4. Results: A total of 102 participants were randomly assigned (DTx group: n=50, 49%; sham group: n=52, 51%). For the per-protocol analysis, 44 (88%) of the 50 participants in the DTx group and 49 (94%) of the 52 participants in the sham group were included. At 6 weeks, the DTx group showed a significantly greater reduction in pain on the visual analog scale compared with the sham group (–33.64 vs –9.86; between-group difference –23.78, 95% CI –34.15 to –13.41; P<.001). Secondary outcomes also favored the DTx group, with improvements in maximum mouth opening (between-group difference 4.36 mm, 95% CI 1.92-6.81 mm; P<.001), Jaw Functional Limitation Scale-20 scores (–1.02, 95% CI –1.63 to –0.42; P=.005), and Oral Behaviors Checklist scores (–5.84, 95% CI –10.18 to –1.50; P=.009). No significant between-group difference was observed in Patient Health Questionnaire-4 scores. Adherence was acceptable, as all participants included in the final analysis met the use threshold of at least 66.7%. No serious adverse events were reported. Conclusions: This randomized, sham-controlled trial demonstrated that a mobile-based DTx intervention led to significant improvement in pain at 6 weeks compared with sham control, with additional benefits in jaw function and oral behaviors, although no significant between-group difference was observed in psychological distress. These findings suggest that DTx interventions may serve as a promising and scalable adjunct to conventional care for patients with TMD. Trial Registration: Clinical Research Information Service KCT0009493; https://tinyurl.com/567fexbj

Yoo-Sung Nam, Seung-Eun Lee, Sung-Ah Che, Sang-Yoon Park, Soo-Hwan Byun, Byoung-Eun Yang, Sangmin Yi. JKAOMS 2024;50:367-72. https://doi.org/10.5125/jkaoms.2024.50.6.367

The rising demand for dental implants necessitates addressing anatomical challenges, particularly the shape of the mandible. Incorrectly angling implants can cause lingual perforations, risking damage to the inferior alveolar artery and nerve. This study analyzed 96 cone-beam computed tomography images from individuals aged 20 to 70 (8 males and 8 females) to evaluate mandibular anatomy in four areas: left and right sides and the first and second molars. Mandibular shapes were classified into U, C, and P types. U-shaped mandibles, with a wider crest width, pose the highest risk of lingual perforation. Measurements for U-shaped types included concavity angle, length, and depth. Statistical analyses (T-tests and ANOVA) with a 95% confidence interval showed no significant differences between the left and right sides. However, significant differences based on gender, age, and tooth type were found. The study found U-shapes in 34.6% of cases, P-shapes in 28.9%, and C-shapes in 36.5%, with U-shapes more common in second molars. Understanding these variations enhances the safety and effectiveness of implant procedures and oral surgeries.

Background: Temporomandibular disorders (TMDs) are common chronic conditions involving orofacial pain and functional limitations. Digital therapeutics (DTx) have demonstrated efficacy in TMD management; yet, the behavioral and clinical mechanisms underlying treatment response remain poorly characterized, particularly whether behavioral modification or DTx engagement intensity drives therapeutic benefit. Objective: This study aimed to investigate the behavioral mechanisms, responder profiles, and moderators of clinical response to a DTx intervention for TMD through a post hoc analysis integrating self-reported, server-derived, and clinician-rated outcome measures. Methods: We performed a post hoc secondary analysis of a multicenter, double-blind, sham-controlled randomized superiority trial conducted at 2 tertiary care centers in South Korea. The per-protocol cohort comprised 93 participants (DTx: n=44; sham: n=49). Five complementary analyses were applied: responder logistic regression at ≥30%, ≥50%, and ≥70% Visual Analog Scale (VAS) pain-reduction thresholds; subgroup comparison by Oral Behaviors Checklist (OBC) modifier status; causal mediation analysis using the potential outcomes framework with bootstrap CIs; week-4 sensitivity analysis; and moderator analysis testing the treatment×Patient Health Questionnaire-4 (PHQ-4) interaction on VAS change. Results: DTx assignment was consistently associated with clinically meaningful pain reduction across all 3 responder thresholds (adjusted odds ratios [ORs] 5.39, 95% CI 1.72‐16.94 at ≥30%; 3.21, 95% CI 1.14‐8.99 at ≥50%; and 3.45, 95% CI 1.12‐10.63 at ≥70%; all P <.05). Mediation analysis suggested that approximately 29.1% of the total VAS treatment effect may be transmitted via OBC-defined behavioral modification (natural indirect effect −6.91 mm; 95% CI −13.23 to −0.58; P =.03), with the mediated proportion rising from 19.6% to 30.2% as responder thresholds became more stringent. Participants with OBC modifiers achieved substantially greater pain reduction than nonmodifiers (−45.71 vs −22.61 mm; difference −23.11; 95% CI −36.97 to −9.24; P <.01) despite no significant differences in any objective DTx engagement metric. Treatment ORs were 33%‐42% higher at week 4 than at the 6-week end point (week-4 ORs 7.15, 95% CI 2.39‐21.32 at ≥30%; 4.48, 95% CI 1.68‐11.94 at ≥50%; and 4.91, 95% CI 1.74‐13.87 at ≥70%), suggesting that week 4 may be a candidate time point for future adaptive protocols. Baseline psychological distress (PHQ-4 ≥3) appeared to moderate the treatment response (interaction β=−19.63; 95% CI −37.86 to −1.39; P =.04). Conclusions: Sham-controlled randomized trials in TMD that empirically differentiate behavioral realization from digital engagement volume remain scarce. Behavioral modification, rather than engagement volume, appears to be an important pathway associated with DTx efficacy and may mediate approximately 29% of the pain-reduction effect under exploratory causal assumptions. This advances mechanism-based evaluation of DTx beyond engagement-based surrogates. Week 4 may represent a promising candidate for future adaptive protocols, and baseline psychological distress may warrant investigation for precision patient selection. These preliminary findings should be corroborated by future prospective studies and further mechanistic investigations.

Background/Objectives: Occlusal splints are widely used for temporomandibular disorders (TMDs), but direct evidence comparing ready-made soft splints with customized hard stabilization splints remains limited. This exploratory randomized study compared the short-term clinical outcomes of a ready-made soft splint and a digitally fabricated, customized 3D-printed hard stabilization splint, representing two distinct fabrication and delivery workflows. Methods: Seventy adults with TMDs were randomized 1:1 to a customized hard splint fabricated using intraoral scanning and digital light processing 3D printing or to a ready-made soft splint (n = 35 per group); 68 completed follow-up. Modified Helkimo index scores were assessed at baseline (T0), 4 weeks (T1), and 12 weeks (T2). Results: Scores decreased significantly from baseline in both groups at T1 and T2 (all p < 0.001). No statistically significant between-group difference was detected in change from baseline to T1 (Hodges–Lehmann median difference, hard minus soft = 0.00; 95% CI, −1.00 to 1.00; p = 0.573) or T2 (−1.00; 95% CI, −2.00 to 0.00; p = 0.209). Conclusions: No statistically significant difference in short-term clinical improvement was detected between the two splint groups. This finding should not be interpreted as evidence of equivalence or non-inferiority. Ready-made soft splints may have a limited, hypothesis-generating role as a short-term conservative or bridging option for selected patients, but adequately powered, prospectively registered non-inferiority trials are needed to define their clinical role. Trial Registration: CRIS KCT0012318 (retrospectively registered).