1.Assess ear acupuncture's impact on reducing lidocaine anesthesia onset during posterior mandibular tooth extraction.
2.Compare lidocaine anesthesia duration between intervention and control groups.
3.Evaluate post-surgery pain disparity between intervention and control groups at specified intervals
4.Compare anesthetic quantities used in intervention versus control groups
5.Examine acupuncture's role as supplementary anesthesia in post-surgery pain alleviation
Design
Two Period Cross Over Clinical Trial. Patients are examined in two periods and two periods, unblinded, randomized, block randomization using the Randomization.com
Settings and conduct
Bushehr University's dental clinic methodically selects patients, reviews medical history, obtains consent, uses ear acupuncture, and administers lidocaine anesthesia. Timing the onset of numbness, they perform surgery or extraction. Patients receive a post-surgery pain form. For subsequent extractions on the opposite side, acupuncture isn't used beforehand.
Participants/Inclusion and exclusion criteria
Entry criteria: healthy patients who need mandibular anesthesia. Those who have similar teeth in two opposite quadrants in the lower jaw that need to be extracted. People who do not have needle phobia.
People who are not addicted.
Exclusion criteria: All patients who need non-lidocaine anesthesia, those who have an infection at the place where the needles are inserted. Pregnant people. Presence of dental abscess, presence of large scars caused by jaw and face surgeries
Intervention groups
Intervention group: patients who receive ear acupuncture with lidocaine anesthesia
Control group: patients who only receive lidocaine anesthesia.
Main outcome variables
1Anesthesia effect time
2Elapsed time until taking the first pain medication after dental surgery
3The amount of pain after surgery
4 Amount of anesthetic used
5 Complications of ear acupuncture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240109060660N1
Registration date:2024-01-15, 1402/10/25
Registration timing:registered_while_recruiting
Last update:2024-01-15, 1402/10/25
Update count:0
Registration date
2024-01-15, 1402/10/25
Registrant information
Name
Mehrnoosh Fathi alikordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 3139
Email address
mehrnooshfathi8118@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-13, 1402/10/23
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using auricular acupuncture in reducing the onset time of lidocaine anesthesia in molars extraction
Public title
Investigating the effect of using auricular acupuncture in reducing the onset time of lidocaine anesthesia in molars extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients who need mandibular anesthesia. Those
Those who have similar teeth in two opposite quadrants in the lower jaw that need to be extracted.
who do not have needle phobia.
People who are not addicted.
Exclusion criteria:
All patients requiring non-lidocaine anesthesia.
those with infection at the site of needle insertion.
Pregnant women
Presence of dental abscess
presence of large scars caused by jaw and face surgeries
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
Tooth extraction or surgery using auricular acupuncture before anesthesia, tooth extraction or surgery without aurucular acupuncture
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization with a block size of 6 is used. A block randomization design will be generated using the free website below.
(Seed: 188521504972600) https://www.sealedenvelope.com
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
No. 1, 28th Alley, Vokala Ave., Iman shomali
City
Shiraz
Province
Fars
Postal code
7186645847
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.BPUMS.REC.1402.223
Health conditions studied
1
Description of health condition studied
Investigating the effect of using ear acupuncture as adjunctive anesthesia in surgery or extraction of posterior mandibular teeth
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Investigating the effect of using ear acupuncture as an auxiliary anesthesia in surgery or extracting posterior mandibular teeth on pain after surgery.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anesthesia effect time
Timepoint
After the end of mandibular block anesthesia until lip tingling
Method of measurement
Using a stopwatch
Secondary outcomes
1
Description
The amount of pain after surgery
Timepoint
Immediately after the surgery, 6, 12, 24, 36 and 48 hours after the surgery and also between these intervals, there is pain in the face.
Method of measurement
Using the Defense and Veterans Pain Rating Scale
2
Description
Elapsed time until taking the first pain medication after dental surgery
Timepoint
After tooth extraction
Method of measurement
Patient self-reporting and hourly basis
3
Description
Amount of anesthetic used
Timepoint
During the tooth extraction process
Method of measurement
Based on the number of anesthetic carpools used
Intervention groups
1
Description
Intervention group: Using ear acupuncture before lidocaine anesthesia. Use of 0.16 x 8 mm Sujok acupuncture needles made of silver or steel. After 10 to 15 minutes, use ASP needles which are made of silver or steel.
Category
Treatment - Other
2
Description
Control group: Use of lidocaine anesthesia before tooth extraction.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr University of Medical Sciences dental clinic
Full name of responsible person
Amrollah Rezaei
Street address
Kuy-e-Bandar، Moallem St
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Fax
+98 77 3345 0235
Email
mehrnooshfathi8118@gmail.com
Web page address
http://bpums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Akram Farhadi
Street address
بوشهر ، بهمنی ، خیابان سلمان فارسی ، پردیس علوم پزشکی ، طبقه اول
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Fax
+98 77 3345 2228
Email
Pkarshenasan@Yahoo.com
Web page address
https://rs.bpums.ac.ir/fa/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehrnoosh Fathi alikordi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 1, 28 Alley, Vokala Av.
City
Shiraz
Province
Fars
Postal code
7186645847
Phone
+98 71 3631 3139
Fax
Email
mehrnooshfathi8118@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehrnoosh Fathi alikordi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 1, 28 Alley, Vokala Av.
City
Shiraz
Province
Fars
Postal code
7186645847
Phone
+98 71 3631 3139
Fax
Email
mehrnooshfathi8118@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehrnoosh Fathi alikordi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 1, 28 Alley, Vokala Av.
City
Shiraz
Province
Fars
Postal code
7186645847
Phone
+98 71 3631 3139
Fax
Email
mehrnooshfathi8118@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available