Desenvolvimento de um protótipo ortopédico intraoral para minimização de cefaleia crônica primária

Abstract

Primary chronic headaches represent a relevant clinical challenge and are frequently managed through predominantly pharmacological approaches, often with limited effectiveness and an increased risk of adverse effects. Growing evidence suggests that biomechanical imbalances of the craniofacial complex and the stomatognathic system may contribute to the onset and maintenance of pain in primary chronic headache conditions. In this context, the present study aimed to develop and clinically evaluate a customized intraoral device, based on functional orthopedic principles of the stomatognathic system, as a therapeutic strategy for primary chronic headaches. This prospective clinical study analyzed 25 patients with primary chronic headache (≥ 2 episodes per week for more than six months). The KM Monoblock Orthopedic Appliance, developed within the scope of this study, was used for 90 days for a minimum of 8 hours per day, aiming to promote mild mandibular advancement, mandibular centralization, and craniofacial biomechanical rebalancing. Pain intensity and frequency (Visual Analog Scale and days/month), functional impact of pain (Brief Pain Inventory), pain body distribution, medication use, daytime sleepiness (Epworth Sleepiness Scale), and structural changes assessed through posteroanterior (PA) cephalometric radiographs were evaluated before and after the intervention. Intraindividual comparisons were performed using the paired Wilcoxon test (α = 5%). After the intervention, a significant reduction in headache intensity was observed, with the median Visual Analog Scale score decreasing from 10 to 2 (p < 0.05), as well as a reduction in monthly headache frequency from 20 to 2 days/month (p < 0.05). 88% of participants no longer met the criteria for chronic headaches, and 36% reported complete absence of pain during the post-intervention period. The functional impact of pain showed a marked reduction, with the total Brief Pain Inventory score decreasing from 72 to 2 (p < 0.05). A reduction in the extent of body pain was also observed, with fewer complaints involving the trunk and limbs, and 72% of participants discontinued the use of analgesic medication. From a biomechanical perspective, cephalometric analyses demonstrated a significant bilateral increase in vertical occlusal dimension (right: from 76.8 mm to 78.5 mm; left: from 75.8 mm to 78.6 mm; p < 0.05) and a reduction in the mandibular deviation angle relative to the facial midline (from 2.57° to 0.92°; p < 0.05). Additionally, a significant reduction in daytime sleepiness was observed, with the mean Epworth Sleepiness Scale decreasing from 9.0 ± 4.1 to 3.3 ± 3.2 points (p < 0.05). These findings suggest that a therapeutic approach grounded in a clinical–biomechanical framework, aimed at correcting craniofacial imbalances and promoting mandibular repositioning, may represent an effective and integrated strategy for the management of primary chronic headaches, with positive effects on pain, function, sleep, and reduced medication dependence.