Extraction of Third Molar Teeth Clinical Trial
Official title:
Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions - a Double Blinded Randomized Controlled Trial
This is a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain after third molar extraction.
Perioperative acupuncture for impacted mandibular third molar extractions - a double blinded
randomized controlled trial.
The extraction of impacted third molar teeth is one of the most common surgical procedures
performed by oral and maxillofacial surgeons. Post operative pain (POP) remains a significant
challenge for all healthcare providers, and is a common complaint after dental and
maxillofacial. NSAIDs are commonly used to treat POP and inflammation following a surgical
procedure, but they are associated with unwanted side effects and can delay post operative
recovery. . Third molar surgeries are associated with significant postoperative morbidity.
Many clinicians have emphasized the necessity for better pain control in patients who undergo
third molar surgery. Two recent systematic reviews of randomized clinical trials evaluating
clinical evidence of the efficacy of acupuncture for postoperative pain control have
concluded that perioperative acupuncture may be a useful adjunct for acute postoperative
pain. The investigators propose a double-blinded, randomized, controlled study on the effect
of perioperative acupuncture on pain in third molar surgery. Methods: 100 patients about to
undergo impacted third molar extraction will be recruited. After signing an informed consent,
patients will be randomized into two groups: real acupuncture and sham acupuncture. In both
groups needles will be placed prior to dental treatment and will be left in place until
treatment ends. Prior to treatment, all participants will fill a dental anxiety
questionnaire. All patients will receive a detailed explanation regarding the dental
procedure. Pre emptive etodolac 400mg will be given prior to starting the procedure. The
operation will be performed under local anesthesia. Upon completion of the extraction, local
lavage will be performed with physiological saline. If necessary, sutures will be placed
using Rapid Vicryl 4/0. Antibiotics will not be given routinely. Patients will be advised to
use Etodolac 400mg every 8 hours for the next 3 days, and to perform mouthwashes using
commercially available Chlorhexidine digluconate 0.2% starting the following day. Patient
follow up and data collection: Pain will be assessed using a VAS (Visual Analog Scale) by an
attending nurse blinded to the randomization status, with no knowledge of acupuncture point
location. VAS score will be recorded 10 minutes after the start of dental treatment and at
treatment's end. Blood pressure and heart rate will be recorded during the procedure every 10
minutes. Post discharge follow up: On the day following discharge patients will be
interviewed by telephone and asked to grade their general pain sensation, their ability to
perform daily functions and the amount and type of analgesics they used. Inclusion criteria:
Otherwise healthy adults above 18y, who are scheduled for an impacted third molar extraction,
signed informed consent. Exclusion criteria: no informed consent, coagulopathy, hematological
disorder, current corticosteroid therapy, known psychiatric disorder, pregnancy,
immunosuppression. Data analysis: Data will be analyzed using standard statistical tests.
Study location: Ziv medical center, department of maxillofacial surgery.
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