Effect of Cannabidiol on the management of Awake bruxism

INTERVENTION: This is a randomized, two‐parallel‐group, triple‐blind, placebo���controlled clinical trial with 44 participants allocated in a 1:1 ratio, with 22 participants in the intervention group and 22 participants in the control group. Randomization will be centralized, with the sequence generated by a computer algorithm by the supervising investigator, who will not participate in recruitment, clinical assessments, intervention, or data analysis. Allocation concealment will be ensured through a secure electronic system and, if necessary, sequentially numbered, opaque, sealed envelopes may be used and opened only after final confirmation of eligibility. The study will be triple‐blind: participants will not know whether they receive cannabidiol or placebo, the clinical researcher responsible for clinical assessments, administration of assessment instruments, follow‐up, and behavioral management will remain blinded to the intervention received, and the statistical analyst will analyze coded groups without knowledge of treatment identity until completion of the primary analyses. The active product and placebo will be provided as capsules indistinguishable in appearance, weight, color, odor, packaging, labeling, and route of administration. All participants will receive standardized behavioral management for awake bruxism, consisting of an initial face‐to‐face session lasting approximately 30 minutes with instructions on mandibular resting position, identification of contextual triggers, and strategies to interrupt the behavior, followed by weekly remote reinforcement lasting approximately 5 to 8 minutes throughout the eight‐week intervention period. The intervention group will receive oral capsules containing an oily Cannabis sativa L. formulation rich in cannabidiol for eight weeks, with gradual dose titration every three days: days 1 to 3, 5 milligrams three times daily, totaling 15 milligrams per day; days 4 to 6, 7.5 milligrams three times daily, totaling 22.5 milligrams per day; days 7 to 9, 11.25 milligrams three times daily, totaling 33.75 milligrams per day; and from day 10 onward, 16.87 milligrams three times daily or 16.87 milligrams in the morning and 33.75 milligrams at night, totaling 50.61 milligrams per day, with the dose maintained or adjusted according to tolerability and functional response. The control group will receive placebo capsules containing an inert vehicle without active Cannabis sativa L. compounds, with the same dosing schedule, simulated titration, number of capsules, and administration instructions as the intervention group for eight weeks. Adherence and adverse events will be assessed weekly during the eight‐week intervention through remote contact, self‐report, recording of clinical events, and, during face‐to‐face visits, checking of remaining capsules. Three face‐to‐face assessments will be performed: the first for medical and dental history, clinical dental examination, eligibility assessment, informed consent, and initiation of baseline assessment; the second after baseline assessment for confirmation of eligibility, adm CONDITION: Bruxism ; Other somatoform disorders F45.8 SECONDARY OUTCOME: A reduction in mandibular functional limitation is expected. The outcome will be assessed using the 8‐item Jaw Functional Limitation Scale before and after the intervention. The score will be obtained by summing the eight items, each scored from 0 to 10, resulting in a total score ranging from 0 to 80, with higher scores indicating greater mandibular functional limitation and a reduction after the intervention indicating improvement A reduction in orofacial pain intensity is expected. The outcome will be assessed using the Visual Analog Scale for pain before and after the intervention. Pain intensity will be determined by measuring the distance in centimeters from the beginning of the scale to the mark made by the participant, resulting in a value ranging from 0 to 10, with higher values indicating greater pain intensity and a reduction after the intervention indicating improvement A reduction in pain catastrophizing is expected. The outcome will be assessed using the Pain Catastrophizing Scale before and after the intervention. The score will be obtained by summing the 13 items, resulting in a score ranging from 0 to 52, with higher scores indicating greater pain catastrophizing and a reduction after the intervention indicating improvement A reduction in pain vigilance and attention to pain is expected. The outcome will be assessed using the Pain Vigilance and Awareness Questionnaire before and after the intervention. The score will be obtained by summing the 14 items, resulting in a score ranging from 0 to 56, with higher scores indicating greater pain vigilance and a reduction after the intervention indicating improvement A reduction in self‐reported sleep bruxism is expected. The outcome will be assessed using the Structured Self‐Report for Sleep Bruxism Assessment before and after the intervention. The result will be classified dichotomously as presence or absence of a positive self‐report, with presence defined by an affirmative response to at least one item related to grinding or clenching during sleep and/or signs perceived upon awakening, and a reduction in the proportion of participants with a positive self‐report after the intervention indicating exploratory improvement A reduction in the frequency of oral parafunctional behaviors is expected. The outcome will be assessed using the Oral Behaviors Checklist before and after the intervention. The total score will be obtained by summing the 21 items, ranging from 0 to 84, with higher scores indicating a greater frequency of oral parafunctional behaviors and a reduction in the score after the intervention indicating improvement A reduction in the severity of anxiety symptoms is expected. The outcome will be assessed using the 7‐item Generalized Anxiety Disorder Scale before and after the intervention. The score will be obtained by summing the seven items, resulting in a score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms and a reduction after the intervention indicating improvement Adequate safety and tolerability of the cannabidiol administration protocol are expected throughout the eight‐week intervention. The outcome will be assessed through active monitoring of adverse events during weekly contacts and a face‐to‐face assessment at the end of the intervention. The number and proportion of participants experiencing adverse events, the type of event, its intensity classified as mild, moderate, or severe, its temporal relationship with the intervention, and the actions taken, including maintenance or dose adjustment, intervention discontinuation, or clinical referral when necessary, will be recorded An improvement in oral health‐related quality of life is expected. The outcome will be assessed using the 14‐item Oral Health Impact Profile before and after the intervention. The score will be obtained by summing the 14 items, resulting in a score ranging from 0 to 56, with higher scores indicating a greater negative impact of oral health on quality of life and a reduction after the intervention indicating improvement An improvement in overall quality of life is expected. The outcome will be assessed using the World Health Organization Quality of Life Brief Version questionnaire before and after the intervention, evaluating the physical, psychological, social relationships, and environment domains. Scores will be calculated for each domain and transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life and an increase in scores after the intervention indicating improvement An improvement in sleep quality is expected. The outcome will be assessed using the Pittsburgh Sleep Quality Inde Xbefore and after the intervention. The global score will be obtained by summing the seven components of the instrument, resulting in a score ranging from 0 to 21, with scores greater than 5 indicating impaired sleep quality and a reduction in the score after the intervention indicating improvement INCLUSION CRITERIA: Age between 18 and 55 years; self‐reported presence of awake bruxism; provision of written informed consent; abstinence from Cannabis sativa‐derived products and/or the plant in natura, by any route of administration, for at least two weeks before the baseline Ecological Momentary Assessment, and willingness to refrain from using such products throughout the entire study period. PRIMARY OUTCOME: A reduction in the relative frequency of mandibular activity compatible with awake bruxism is expected. The outcome will be assessed using Ecological Momentary Assessment, with six to eight alerts per day for seven consecutive days at baseline, seven consecutive days during the eighth week of intervention, and seven consecutive days beginning 14 days after the end of the intervention. Relative frequency will be calculated by dividing the sum of responses indicating light tooth contact and mandibular clenching by the total number of valid responses, resulting in a value ranging from 0 to 1, with higher values indicating greater frequency of awake mandibular activity and a reduction from baseline to the eighth week indicating improvement, while the post‐intervention assessment will evaluate maintenance of the effect