Impacted Lower Third Molar, Postoperative Pain, Stress, Psychological
Conditions
Keywords
Electroacupuncture, Dental Anxiety, Third Molar Surgery, Cortisol, Alpha-Amylase, Substance P
Brief summary
This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.
Detailed description
Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation. This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention. An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.
Interventions
PROCEDUREElectroacupuncture
Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation.
PROCEDURESham Acupuncture
Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect.
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to group assignment through the use of a sham acupuncture procedure that mimics the active intervention without therapeutic effect. Outcome assessment will be performed using standardized measures, and laboratory analyses will be conducted on coded samples without knowledge of group allocation.
Intervention model description
Participants will be randomized in a 1:1:1 ratio into three parallel groups: electroacupuncture, sham acupuncture, and control. Each participant will receive only one assigned intervention, and outcomes will be compared between groups.
Eligibility
Sex/Gender
ALL
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 25-35 years * ASA physical status I-II * Indication for ambulatory surgical extraction of an impacted lower third molar * Ability to understand the study procedures and provide written informed consent * Willingness to comply with study procedures, including saliva sampling protocol * Ability to abstain from food, beverages, and oral hygiene procedures for at least 1 hour prior to saliva sampling
Exclusion criteria
* Pregnancy * Epilepsy * Presence of a pacemaker or other active electronic implant * Coagulation disorders * Active infection at the site of acupuncture * Systemic inflammatory diseases * Oral inflammatory conditions (e.g., gingivitis or periodontitis) * Hyposalivation * Chronic opioid use * Psychiatric conditions that may affect pain or stress assessment * Use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antibiotics within 7 days prior to the procedure * Menstruation at the time of saliva sampling * Inability or unwillingness to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Pain Intensity | Baseline and 30 minutes after surgical extraction | Perioperative pain intensity assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | Baseline and 30 minutes after surgical extraction | Perceived stress assessed using a Numeric Rating Scale (NRS 0-10), where 0 indicates no stress and 10 indicates the highest perceived stress, and the 10-item Perceived Stress Scale (PSS-10); higher scores on both scales indicate greater perceived stress and a worse outcome. |
| Salivary Cortisol Levels | Baseline and 30 minutes after surgical extraction | Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA). |
| Salivary Alpha-Amylase Levels | Baseline and 30 minutes after surgical extraction | Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA). |
| Salivary Substance P Levels | Baseline and 30 minutes after surgical extraction | Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response. |
| Systolic Blood Pressure | Baseline and immediately after surgical extraction | Systolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg). |
| Diastolic Blood Pressure | Baseline and immediately after surgical extraction | Diastolic arterial blood pressure measured noninvasively using a validated automated digital monitor as an indicator of autonomic response, reported in millimeters of mercury (mmHg). |
| Heart Rate | Baseline and immediately after surgical extraction | Heart rate measured using a validated automated digital monitor as an indicator of autonomic response, reported in beats per minute (bpm). |
Countries
Croatia
Contacts
CONTACTIvan Salaric, Associate Professor, PhD
CONTACTMonika Ilić, MD
STUDY_CHAIRJasminka Peršec, Associate Professor, PhD
University Hospital Dubrava
Outcome results
None listed