Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-35
SponsorUniversity of Zagreb
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Epilepsy
Presence of a pacemaker or other active electronic implant
Coagulation disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
Procedure/SurgeryElectroacupuncture 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.
Sham Acupuncture
Procedure/SurgerySham 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Electroacupuncture GroupExperimental treatment 1 intervention
Group B: Sham Acupuncture GroupSham comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Perioperative Pain Intensity
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.
Time frame
Baseline and 30 minutes after surgical extractionSecondary outcomes
1
Perceived Stress
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.
Time frame
Baseline and 30 minutes after surgical extraction2
Salivary Cortisol Levels
Salivary cortisol concentrations measured as a biomarker of stress response using enzyme-linked immunosorbent assay (ELISA).
Time frame
Baseline and 30 minutes after surgical extraction3
Salivary Alpha-Amylase Levels
Salivary alpha-amylase concentrations measured as an indicator of sympathetic activity using enzyme-linked immunosorbent assay (ELISA).
Time frame
Baseline and 30 minutes after surgical extraction4
Salivary Substance P Levels
Salivary substance P concentrations measured using ELISA as a biomarker of nociceptive response.
Time frame
Baseline and 30 minutes after surgical extractionSponsors and contacts
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Source ClinicalTrials.gov
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