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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tooth Extraction Molar, Third Pain, Postoperative Trismus Edema Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Active acupuncture

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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.

Placebo acupuncture

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.

Group Type PLACEBO_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

17 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes