Clinical trial NCT03545022: Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars
Official title: Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Molar, Third
Pain, Postoperative
Trismus
Edema
Anxiety
Keywords: third molar
acupuncture
pain
edema
trismus
anxiety
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. Patients who met the study criteria were randomized to the type of acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery (right or left).

Detailed description: Studies using acupuncture have shown promising results in the control of pain, edema, trismus and anxiety control. The use of this technique is interesting considering the negative effects of excessive use of medicines and the side effects of medications which are the most common treatment used for the control of these complications. However, there are no reports in the literature that evaluated the effects of acupuncture on the control of these variables following mandibular third molar extraction, using the placebo-needle design and blinding the patients, operators, and evaluators. Therefore, the aim of this split-mouth randomized triple-blind clinical trial was to compare the efficacy of acupuncture and placebo acupuncture for the control of pain, edema, trismus and preoperative anxiety in the extraction of third molars.

Eligibility criteria: Inclusion Criteria:

* Patients with indication for bilateral extraction of asymptomatic mandibular third molars in the position class IIB, according to the classification of Pell \& Gregory (1933).

Exclusion Criteria:

* Previous use of any type of medication in the 15 days prior to the study;
* Hypersensitivity to drugs, substances or any materials used in this experiment;
* Pregnancy or lactation;
* Previous case of pericoronitis;
* People who have previously undergone any kind of acupuncture treatment.

Primary outcomes:
measure: Presence and intensity of postoperative pain at 24 hours following the surgery
timeFrame: The marking was performed at 24 hours postoperatively.
measure: Presence and intensity of postoperative pain at 48 hours following the surgery.
timeFrame: The marking was performed at 48 hours postoperatively.
measure: Presence and intensity of postoperative pain at 72 hours following the surgery.
timeFrame: The marking was performed at 72 hours postoperatively.
measure: Change from baseline facial swelling (edema) at 24 hours following the surgery.
timeFrame: The measurements were obtained preoperatively (baseline) and at 24 hours following the surgery.
measure: Change from baseline facial swelling (edema) at 48 hours following the surgery.
timeFrame: The measurements were obtained preoperatively (baseline) and at 48 hours following the surgery.
measure: Change from baseline facial swelling (edema) at 72 hours following the surgery.
timeFrame: The measurements were obtained preoperatively (baseline) and at 72 hours following the surgery.
measure: Change from baseline facial swelling (edema) at 7 days following the surgery.
timeFrame: The measurements were obtained preoperatively (baseline) and at 7 days following the surgery.
measure: Change from baseline mouth opening at 24 hours following the surgery.
timeFrame: The measurement was determined in the preoperative period (baseline) and at the period of 24 hours following the surgery.
measure: Change from baseline mouth opening at 48 hours following the surgery.
timeFrame: The measurement was determined in the preoperative period (baseline) and at the period of 48 hours following the surgery.
measure: Change from baseline mouth opening at 72 hours following the surgery.
timeFrame: The measurement was determined in the preoperative period (baseline) and at the period of 72 hours following the surgery.
measure: Change from baseline mouth opening at 7 days following the surgery.
timeFrame: The measurement was determined in the preoperative period (baseline) and at the period of 7 days following the surgery.
measure: Change of anxiety state scores using STAI questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
timeFrame: The STAI-S questionnaires were applied before the preoperative acupuncture and after acupuncture.
measure: Change of anxiety state scores using a Visual Analogue Scale (VAS) questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
timeFrame: The VAS were applied before the preoperative acupuncture and after acupuncture.
Secondary outcomes:
measure: Duration of surgery
timeFrame: From the time of the initial incision to the time of the final suture.
measure: Number of painkillers tablets
timeFrame: By the seventh postoperative day.
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Jequitinhonha and Mucuri Valleys
name: Anna Catharina V Armond
role: PRINCIPAL_INVESTIGATOR
References: