Authors
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Fundação Universidade de Pernambuco -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2026
INTERVENTION: This is a randomized split‐mouth clinical trial with single blinding of the statistician. A total of 40 participants will be enrolled, and all participants will undergo both interventions, serving as their own controls; therefore, no parallel groups will be included. The order of the surgical sessions (morning and afternoon) and the side of the first tooth extraction (right or left) will be determined by randomization performed by an assistant researcher using a random sequence generated on the Random.org platform. Allocation will be performed using opaque, sealed, and sequentially numbered envelopes. The statistician responsible for data analysis will remain blinded to the intervention allocation and will perform all analyses without knowledge of the experimental period assignments. Each participant will undergo the surgical extraction of two impacted mandibular third molars, with a minimum interval of four weeks between procedures. In both interventions, participants will receive 8 mg of dexamethasone and two 500 mg capsules of amoxicillin one hour before surgery, local anesthesia with 2% mepivacaine associated with epinephrine 1:100,000, surgical extraction performed according to a standardized surgical protocol, and postoperative ibuprofen 600 mg every eight hours for three days, with paracetamol combined with codeine provided as rescue medication when necessary. Pain will be assessed at 6, 12, 24, 48, and 72 hours; edema, trismus, and superficial temperature will be evaluated preoperatively and at 72 hours and 7 days postoperatively; hemodynamic parameters will be assessed immediately before surgery and throughout the surgical procedure; anxiety will be assessed at the initial consultation and on the day of surgery; and salivary cortisol concentration will be measured at the initial consultation and immediately before each surgical procedure. CONDITION: A14.549.167.860.525.500 dexamethasone; hydrocortisone; inflammation; pain; edema; trismus; hemodynamics; dental anxiety ; Molar, Third SECONDARY OUTCOME: To evaluate the secondary outcomes related to systemic immunoinflammatory indices and participant satisfaction following mandibular third molar extraction. Systemic immunoinflammatory indices will be calculated based on laboratory parameters obtained from blood samples, including neutrophil‐to‐lymphocyte ratio (NLR), platelet‐to‐lymphocyte ratio (PLR), lymphocyte‐to‐monocyte ratio (LMR), systemic immune‐inflammation inde X(SII), systemic inflammation response inde X(SIRI), and aggregate inde Xof systemic inflammation (AISI). Global participant satisfaction will be assessed using a five‐point Likert scale, with scores recorded on the seventh postoperative day INCLUSION CRITERIA: Male and female participants; aged 18 to 45 years; requiring the extraction of two mandibular third molars with similar surgical difficulty; healthy individuals or individuals with controlled systemic diseases; absence of infections, pathological conditions, or fractures with clinical repercussions at the surgical site; no use of antimicrobial, anti‐inflammatory, or analgesic medications within the 15 days preceding study enrollment PRIMARY OUTCOME: To evaluate the primary outcomes related to the inflammatory, physiological, and psychological responses following mandibular third molar extraction. Pain will be assessed using the Visual Analogue Scale (VAS), with scores ranging from 0 to 10 recorded at 6, 12, 24, 48, and 72 hours after surgery. Edema will be evaluated through linear facial measurements, with differences between preoperative and postoperative periods assessed after 72 hours and seven days. Trismus will be assessed by measuring maximum mouth opening, with variations in millimeters compared with baseline preoperative values evaluated after 72 hours and seven days. Surface temperature will be assessed using infrared thermography, with temperature variations between the evaluated periods being recorded. Blood pressure, heart rate, peripheral oxygen saturation, and respiratory rate will be assessed using a multiparameter monitor, with their variations recorded during the preoperative and intraoperative periods. Anxiety levels will be assessed using the Modified Dental Anxiety Scale (MDAS), with scores recorded at the initial consultation and on the day of surgery. Salivary cortisol concentration will be determined using an Enzyme‐Linked Immunosorbent Assay (ELISA), with values obtained at the initial consultation and immediately before each surgical procedure being recorded
Epistemonikos ID: 28fede02dc2822508cc3d424bec2ce66c9d74d14
First added on: Oct 08, 2026