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

Primary Purpose

Tooth Extraction, Molar, Third, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Federal University of the Valleys of Jequitinhonha and Mucuri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction focused on measuring third molar, acupuncture, pain, edema, trismus, anxiety

Eligibility Criteria

17 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active acupuncture

    Placebo acupuncture

    Arm Description

    For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle.The needle measuring 0.25x30mm was used as an active needle. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle as well as the placebo needle were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin.

    For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle. In the placebo needle, the needles were cut in 5mm, to measure 0.25x25mm. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle, as well as the placebo needle, were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Duration of surgery
    The duration of surgery was recorded with a stopwatch in seconds.
    Number of painkillers tablets
    The number of paracetamol tablets taken after the surgery was registered by the patient.

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    May 21, 2018
    Sponsor
    Federal University of the Valleys of Jequitinhonha and Mucuri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03545022
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Federal University of the Valleys of Jequitinhonha and Mucuri

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Extraction, Molar, Third, Pain, Postoperative, Trismus, Edema, Anxiety
    Keywords
    third molar, acupuncture, pain, edema, trismus, anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    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). The randomization was performed by a researcher not involved in the study by lottery. Four papers in two opaque envelopes were used, one with the side of the teeth and another with the protocol of acupuncture treatment to be received, protocol 1 or 2. The patients, the surgeon, the acupuncturist and the investigator were unaware of which acupuncture treatment was used at each surgery (active or placebo). In order to conceal the randomization, the needles for the active and placebo protocol were identical and were delivered to the acupuncturist in two boxes labeled protocol 1 and 2 and the codes were revealed only after completion of the study.
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active acupuncture
    Arm Type
    Active Comparator
    Arm Description
    For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle.The needle measuring 0.25x30mm was used as an active needle. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle as well as the placebo needle were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin.
    Arm Title
    Placebo acupuncture
    Arm Type
    Placebo Comparator
    Arm Description
    For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle. In the placebo needle, the needles were cut in 5mm, to measure 0.25x25mm. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle, as well as the placebo needle, were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Presence and intensity of postoperative pain at 24 hours following the surgery
    Description
    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.
    Time Frame
    The marking was performed at 24 hours postoperatively.
    Title
    Presence and intensity of postoperative pain at 48 hours following the surgery.
    Description
    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.
    Time Frame
    The marking was performed at 48 hours postoperatively.
    Title
    Presence and intensity of postoperative pain at 72 hours following the surgery.
    Description
    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.
    Time Frame
    The marking was performed at 72 hours postoperatively.
    Title
    Change from baseline facial swelling (edema) at 24 hours following the surgery.
    Description
    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).
    Time Frame
    The measurements were obtained preoperatively (baseline) and at 24 hours following the surgery.
    Title
    Change from baseline facial swelling (edema) at 48 hours following the surgery.
    Description
    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).
    Time Frame
    The measurements were obtained preoperatively (baseline) and at 48 hours following the surgery.
    Title
    Change from baseline facial swelling (edema) at 72 hours following the surgery.
    Description
    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).
    Time Frame
    The measurements were obtained preoperatively (baseline) and at 72 hours following the surgery.
    Title
    Change from baseline facial swelling (edema) at 7 days following the surgery.
    Description
    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).
    Time Frame
    The measurements were obtained preoperatively (baseline) and at 7 days following the surgery.
    Title
    Change from baseline mouth opening at 24 hours following the surgery.
    Description
    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.
    Time Frame
    The measurement was determined in the preoperative period (baseline) and at the period of 24 hours following the surgery.
    Title
    Change from baseline mouth opening at 48 hours following the surgery.
    Description
    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.
    Time Frame
    The measurement was determined in the preoperative period (baseline) and at the period of 48 hours following the surgery.
    Title
    Change from baseline mouth opening at 72 hours following the surgery.
    Description
    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.
    Time Frame
    The measurement was determined in the preoperative period (baseline) and at the period of 72 hours following the surgery.
    Title
    Change from baseline mouth opening at 7 days following the surgery.
    Description
    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.
    Time Frame
    The measurement was determined in the preoperative period (baseline) and at the period of 7 days following the surgery.
    Title
    Change of anxiety state scores using STAI questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
    Description
    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.
    Time Frame
    The STAI-S questionnaires were applied before the preoperative acupuncture and after acupuncture.
    Title
    Change of anxiety state scores using a Visual Analogue Scale (VAS) questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
    Description
    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.
    Time Frame
    The VAS were applied before the preoperative acupuncture and after acupuncture.
    Secondary Outcome Measure Information:
    Title
    Duration of surgery
    Description
    The duration of surgery was recorded with a stopwatch in seconds.
    Time Frame
    From the time of the initial incision to the time of the final suture.
    Title
    Number of painkillers tablets
    Description
    The number of paracetamol tablets taken after the surgery was registered by the patient.
    Time Frame
    By the seventh postoperative day.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anna Catharina V Armond
    Organizational Affiliation
    Federal University of Jequitinhonha and Mucuri Valleys
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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