The effect of auricular acupuncture on the success of inferior alveolar nerve block in mandibular teeth with irreversible pulpitis
Design
Randomized, double blind trial with control group and parallel group design
Settings and conduct
In the experimental group, ASP acupuncture needle will be inserted on acupuncture point for dental pain control and sticking plaster will be used on that.
In control group a real puncture of needle will not happen and only sticking plaster will be used on points.
10 minutes after acupuncture, an endodontis will administer IANB injection in 60 seconds, based on a standard IANB method.
After 15 minutes patients who will not report lip numbness will be excluded from study because this is a failed IANB. If they report lip numbness, endodontic procedure will be started.
The patients will be instructed to report pain experienced during cavity preparation of dentin, exposure of pulp chamber and inserting initial file . Whenever a patient reports severe pain (>30 mm on VAS of 100 mm), a supplementary injection will be performed if they ask and that IANB will be considered unsuccessful. At the end of the endodontics procedure , the acupuncture’s ASPs will be removed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have a mandibular molar with irreversible pulpitis ,Between 18 and 65 years old. Non-inclusion criteria:
Pregnancy;
Systemic disease;
Using alcohol, drug or smoking; taking any corticosteroid ,analgesic or antidepressant; sensitivity to lidocaine; periapical radiolucency.
Intervention groups
In the experimental group,ASP acupuncture needle will be inserted on acupuncture point for dental pain control and sticking plaster will be used on that.
In control group a real puncture of needle will not happen and only sticking plaster will be used on points.
Main outcome variables
Mandibular anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041724N1
Registration date:2019-01-06, 1397/10/16
Registration timing:retrospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Ehsan Esnaashari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2279 3163
Email address
e_esnaashari@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-08, 1397/09/17
Expected recruitment end date
2018-12-25, 1397/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of auricular acupuncture on the success of inferior alveolar nerve block among patients with irreversible pulpitis in mandibular teeth
Public title
The effect of auricular acupuncture on nerve block injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a mandibular molar with irreversible pulpitis . These teeth will be evaluated via an electric pulp test and a cold test
Patients Between 18 and 65 years old
Patients who agree to participate in this study
Exclusion criteria:
Pregnancy
Systemic and mental disease
Using alcohol, any drug and smoking
taking any analgesic drugs in last 6 hours
using any type of antidepressant medication such as TCA and SSRIs that could affect the perception of pain
using any type of corticosteroid
sensitivity to lidocaine
patient’s age under 18 and over 65
periapical radiolucency or even a widening of the periodontal ligament space in radiography
patients who do not report lip numbness during15 minute after injection
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the patients, 56 papers will be numbered 1 to 56, and the first 28 papers will be placed individually in a red sealed envelope; the remaining 28 will be placed individually in a blue sealed envelope. Each female participant will be instructed to select a red sealed envelope, and each male participant will be asked to select blue one.
Upon opening the envelopes, based on the number (odd numbers for the auricular acupuncture group and even numbers for the control
group), they will be assigned to 1 of the 2 corresponding groups. This ensures an equal number of male and female participants per group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical observer:
An instructed person will apply acupuncture, and a second investigator who is an endodontist administers IANB injection and endodontic procedure will be done. No one knows patients belong to which group , except who applies acupuncture so others are blind.
Patient:
In the acupuncture experimental group, the acupuncture points will be selected by acupuncture probe. An ASP acupuncture needle will be inserted at mentioned points on the side of the subjected tooth and sticking plaster will be used on that. In control group same points will be find by acupuncture probe but acupuncture needle will be inserted at other points which have no effect on dental pain and sticking plaster will be used on those points . At the end of the endodontics procedure , the acupuncture’s ASPs and sticking plasters will be removed so patients will not understand the difference and they are blind.
The person who evaluates the result:
The same person who accomplish endodontic procedure will ask about patient's pain during procedure(who is blind) and at last gives the result to the person who applies acupuncture (who is not blind) .
Data analyzer:
The person who analyzes data , will not know patients belong to which group and therefore he will be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Central organizationn of Islamic Azad University
Street address
No 9, Neyestan 9 ,Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.003
Health conditions studied
1
Description of health condition studied
mandibular molar with irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Amount of pain reported by patient on 100 mm type of visual analog scale
Timepoint
during cavity preparation of dentin, exposure of pulp chamber and inserting initial file
Method of measurement
100 mm type of visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the acupuncture experimental group, the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe. An ASP acupuncture needle will be inserted at mentioned points on the side of the subjected tooth and sticking plaster will be used on that.
Category
Treatment - Devices
2
Description
Control group: In the Control group the same procedure will be mimiced . the acupuncture point for dental pain control and pain control in mandible, and also Shen Men and Talamus points wil be selected by acupuncture probe but a real puncture of needle will not happen at mentioned points and only sticking plaster will be used on those points.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Tehran,Dental Branch
Full name of responsible person
Ehsan Esnaashari
Street address
No 9, Neyestan 9, Pasdsran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
E_esnaashari@dentaliau.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Esnaashari
Street address
No 9,Neyestan 9, Pasdsran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
E_esnaashari@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ehsan Esnaashari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
4th floor, No 121, Boostan 9 Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2279 3163
Fax
Email
E_esnaashari@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Esnaashari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
4th floor, No 121, Boostan 9 Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2279 3163
Fax
Email
E_esnaashari@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Esnaashari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
4th floor, No 121, Boostan 9 Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2279 3163
Fax
Email
E_esnaashari@dentaliau.ac.ir
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