AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

-

Exclusion Criteria:no informed consent, coagulopathy, hematological disorder, current corticosteroid therapy, known psychiatric disorder, pregnancy, immunosuppression.

-

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Ziv Medical Center

    Safed, 1008

    daniel lesmes, MD, 972-4-6828619, daniel.l@ziv.health.gov.il

    Recruiting

Other trials in Israel

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.

Being tested
acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02498184
Study groupRoleWhat they receive
real acupunctureExperimentaltraditional chinese acupuncture
Receives: Other: acupuncture
sham acupunctureSham comparatornon effective acupuncture
Receives: Other: acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 Jul 2015 (estimated)
  2. Study startNov 2016
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in