Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions
Primary Purpose
Extraction of Third Molar Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Extraction of Third Molar Teeth
Eligibility Criteria
Inclusion Criteria: Otherwise healthy adults above 18y, who are scheduled for an impacted third molar extraction, signed informed consent.
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Exclusion Criteria:no informed consent, coagulopathy, hematological disorder, current corticosteroid therapy, known psychiatric disorder, pregnancy, immunosuppression.
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Sites / Locations
- Ziv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
real acupuncture
sham acupuncture
Arm Description
traditional chinese acupuncture
non effective acupuncture
Outcomes
Primary Outcome Measures
pain scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498184
Brief Title
Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions
Official Title
Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions - a Double Blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain after third molar extraction.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraction of Third Molar Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real acupuncture
Arm Type
Experimental
Arm Description
traditional chinese acupuncture
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
non effective acupuncture
Intervention Type
Other
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
pain scale
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
daniel lesmes, MD
Phone
972-4-6828619
Email
daniel.l@ziv.health.gov.il
Facility Information:
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
1008
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
daniel lesmes, MD
Phone
972-4-6828619
Email
daniel.l@ziv.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions
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