Comparison between the success inferior alveolar nerve block and teeth with irreversible pulpitis in both supine and upright positions.
Design
A clinical trial with two groups of nerve block in the upright and supine positions.
Settings and conduct
Center of School of Dentistry, Yazd Shahid Sadoughi University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
-Spontaneous & persistent pain in only one mandibular molar with caries.
-Persistent response to cold test.
-Class I & II medical histories.
Exclusion Criteria:
-Patients with a history of allergy to anesthetics.
-Pregnant & breastfeeding patients.
-Patients with pain in more than one tooth.
-Patients with limited mobility or motor activity.
-Patients with a previous history of or suspicious of drug abuse.
Intervention groups
Supine Group
Upright Group
Main outcome variables
The results of this study can be used to inform about the application of inferior alveolar nerve block technique in a better position.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049528N1
Registration date:2020-12-27, 1399/10/07
Registration timing:retrospective
Last update:2020-12-27, 1399/10/07
Update count:0
Registration date
2020-12-27, 1399/10/07
Registrant information
Name
Nooshin Fakhari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3834 1804
Email address
nooshin_67@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-03, 1399/09/13
Expected recruitment end date
2020-12-13, 1399/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of success of inferior alveolar nerve block in irreversible pulpitis teeth in supine and upright positions: A clinical study
Public title
Comparison of success of inferior alveolar nerve block in irreversible pulpitis teeth in supine and upright positions: A clinical study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Spontaneous and persistent pain in only one of the molar teeth with caries so that the tooth responds to the persistent cold test
Medical Histories Class I and Class II Based on the American Society of Anesthesiology
Exclusion criteria:
Patients with a history of allergies
Pregnant & breastfeeding patients
Patients with pain in more than one tooth
Patients with a history of or suspected with any drug abuse
Patients with problems in the spine and neck
Taking any medication that interferes with a person's perception of pain
Any systemic condition that is a contraindication to inferior alveolar nerve block
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected from the qualified statistical population using simple sampling or convenient sampling method. Then, the samples will be assigned into the two intervention and control groups randomly; In so doing, 60 questionnaires will be prepared and labeled as A (30 questionnaires) and B (30 questionnaires); then, at the place of intervention, we will want the patient or his or her companion to choose one of them while he or she is blind about the type of treatment or group (blindness). Finally, we will have 30 patients in each group who are selected randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be performed on patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
School of Dentistry, ُShahid Sadoughi University of Medical Scineces, Imam Reza Sqaure, Yazd, Iran, I. R. ofe
City
Yazd
Province
Yazd
Postal code
8914815698
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.SSU.REC.1398.216
Health conditions studied
1
Description of health condition studied
Inferior alveolar nerve block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Success of anesthesia (block).
Timepoint
15 min
Method of measurement
local anesthesia of commissure (canthus) of the lips
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention Group: Upright Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been made. In one group of anesthesia, the inferior alveolar nerve block (IAN) will be injected by upright method and in the second group, this anesthesia will be performed by supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the upright method, dental chair headrest has a 75-degree angle with the ground and the occlusal plane of the mandibular teeth is parallel to the ground, and during this injection, the practitioner will stand. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared.
Category
Treatment - Drugs
2
Description
Second Intervention Group: Supine Group: In this study, there are two groups of patients who will go to Yazd dental centers for the treatment of mandibular root canal for whom the diagnosis of irreversible pulpitis has been Established. In one anesthesia group, the inferior alveolar nerve block (IAN) will be injected using the upright method and in the second group, the anesthetic will be injected using the supine method. The choice of injection for these two groups will be random. The injection will be done with two carpules of 2% lidocaine with epinephrine 1/80000 (Iran Pharmaceutical Company). In the supine group, the headrest of dental chair is lowered so that the patient's foot is a bit above the head and the patient's body is parallel to the floor. The practitioner will sit during this injection. The success of IAN block will be compared to measuring the numbness of the corner of the lip within 15 minutes after injection. The presence or absence of pain during the preparation of the access cavity will also be compared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd dental centers
Full name of responsible person
Nooshin Fakhari
Street address
School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of
City
Yazd
Province
Yazd
Postal code
8914815698
Phone
+98 35 3621 3870
Email
Nooshin_67@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nooshin Fakhari
Street address
School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of
City
Yazd
Province
Yazd
Postal code
8914815698
Phone
+98 35 3621 3870
Email
Nooshin_67@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Nooshin Fakhari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of
City
Yazd
Province
Yazd
Postal code
8914815698
Phone
+98 35 3621 3870
Email
Nooshin_67@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nooshin Fakhari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of
City
Yazd
Province
Yazd
Postal code
8914815698
Phone
+98 35 3621 3870
Email
Nooshin_67@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nooshin Fakhari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Sadoughi University of Medical Sciences, Imam Reza Square, Yazd, Iran, I. R. of
City
Yazd
Province
Yazd
Postal code
8914815698
Phone
+98 21 8670 5503
Email
Nooshin_67@ymail.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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available