Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars

Anxiety Clinical Trial

Official title:

Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545022
• Other study ID #: 1.688.806
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2018
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Edema
• Molar, Third
• Pain, Postoperative
• Tooth Extraction
• Trismus

Intervention

Procedure:
• Acupuncture
The application of acupuncture was performed in four sessions, 30 minutes prior to surgery, 24, 48 and 72 hours following the surgery, before variables measurements. The points were manually stimulated and the needles were inserted up to 4mm. There were 11 points, applied bilaterally, two of them, point VG20 and Yintang, for anxiety control, only at the preoperative time and not bilateral. The points to reduce pain, edema, and trismus were IG4 (Hegu), F3 (Taichong) and E44 (Neiting), TA21 (Ermen), ID19 (Ting-Kong), E6 (Jiagle) and E7 (Towei) , point B60 (Kunlum) and VB34 (Yanglingquan). All patients received the same treatment in all sessions. After the needle devices were inserted, the needles were re-stimulated manually once after 10 minutes and removed after more 10 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence and intensity of postoperative pain at 24 hours following the surgery	For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.	The marking was performed at 24 hours postoperatively.
Primary	Presence and intensity of postoperative pain at 48 hours following the surgery.	For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.	The marking was performed at 48 hours postoperatively.
Primary	Presence and intensity of postoperative pain at 72 hours following the surgery.	For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.	The marking was performed at 72 hours postoperatively.
Primary	Change from baseline facial swelling (edema) at 24 hours following the surgery.	Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).	The measurements were obtained preoperatively (baseline) and at 24 hours following the surgery.
Primary	Change from baseline facial swelling (edema) at 48 hours following the surgery.	Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).	The measurements were obtained preoperatively (baseline) and at 48 hours following the surgery.
Primary	Change from baseline facial swelling (edema) at 72 hours following the surgery.	Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).	The measurements were obtained preoperatively (baseline) and at 72 hours following the surgery.
Primary	Change from baseline facial swelling (edema) at 7 days following the surgery.	Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).	The measurements were obtained preoperatively (baseline) and at 7 days following the surgery.
Primary	Change from baseline mouth opening at 24 hours following the surgery.	The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.	The measurement was determined in the preoperative period (baseline) and at the period of 24 hours following the surgery.
Primary	Change from baseline mouth opening at 48 hours following the surgery.	The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.	The measurement was determined in the preoperative period (baseline) and at the period of 48 hours following the surgery.
Primary	Change from baseline mouth opening at 72 hours following the surgery.	The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.	The measurement was determined in the preoperative period (baseline) and at the period of 72 hours following the surgery.
Primary	Change from baseline mouth opening at 7 days following the surgery.	The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.	The measurement was determined in the preoperative period (baseline) and at the period of 7 days following the surgery.
Primary	Change of anxiety state scores using STAI questionnaire at the moment before the preoperative acupuncture and after the acupuncture.	Anxiety was evaluated with the Spielberger State-Trait Anxiety Inventory (STAI) questionnaire, translated and validated to Portuguese by Biaggio et al. (1977). The STAI is a validated questionnaire consisting of two parts, each with 20 questions. One part, STAI-S, evaluates the state of anxiety which is defined as anxiety in response to a situation. The other part, STAI-T, evaluates the anxiety trait, defined by the level of anxiety normally felt by the person. The two parts can be scored from 20 to 80, with the highest values indicating the highest rates of anxiety. Values =40 indicate a high level of anxiety and =50 as very high.	The STAI-S questionnaires were applied before the preoperative acupuncture and after acupuncture.
Primary	Change of anxiety state scores using a Visual Analogue Scale (VAS) questionnaire at the moment before the preoperative acupuncture and after the acupuncture.	A visual analog scale (VAS) consisted of a 10cm line, without divisions was used. The patients were instructed to mark the level of anxiety at that moment, with the "0" without anxiety and "10", with a high level of anxiety, that was measured with a ruler later.	The VAS were applied before the preoperative acupuncture and after acupuncture.
Secondary	Duration of surgery	The duration of surgery was recorded with a stopwatch in seconds.	From the time of the initial incision to the time of the final suture.
Secondary	Number of painkillers tablets	The number of paracetamol tablets taken after the surgery was registered by the patient.	By the seventh postoperative day.