Extraction of Third Molar TeethNCT02498184
Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions
A study testing acupuncture in people with Extraction of Third Molar Teeth, run by Ziv Hospital at 1 site in Israel.
Trial summary
This is a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain after third molar extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extraction of Third Molar Teeth
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 1008
daniel lesmes, MD, 972-4-6828619, daniel.l@ziv.health.gov.il
About this study
Official title: Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions - a Double Blinded Randomized Controlled Trial
This is a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain after third molar extraction.
Read the 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.
- Conditions
- Extraction of Third Molar Teeth
- Being tested
- acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| real acupuncture | Experimental | traditional chinese acupuncture Receives: Other: acupuncture |
| sham acupuncture | Sham comparator | non effective acupuncture Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction of Third Molar TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498184
- Sponsor's protocol ID
- 0064-15-ZIV
- Status last verified
- Nov 2017
- First submitted
- 13 Jul 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions - a Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02498184
- Acronym / sponsor ID
- 0064-15-ZIV
- Conditions
- Extraction of Third Molar Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real acupuncture | Experimental | Other: acupuncturetraditional chinese acupuncture |
| sham acupuncture | Sham comparator | Other: acupuncturenon effective acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture | Other | real acupuncture, sham acupuncture |
Primary outcome
pain scale
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Extraction of Third Molar Teeth, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact daniel lesmes, MD (972-4-6828619, daniel.l@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.