Comparison of Success Rate of Inferior Alveolar Nerve Block versus IntraOsseous Injection For Pulpal Anesthesia in The Posterior Mandibular Teeth with Irreversible Pulpitis in patients attending to Afzal dental clinic, Isfahan, Iran 1391-92
Aim: To compare the success rate of inferior alveolar nerve block (IANB) versus intraosseous (IO) injection for pulpal anesthesia in the posterior mandibular teeth with irreversible pulpitis in patients attending to Afzal dental clinic in order to replace the IO as a primary anesthesia in pulp therapy
Design: An interventional randomized single-blinded study, unicenteric, with control group and without placebo
Method: 50 patients aged 18 to 65 years old with at least one posterior mandibular tooth with irreversible pulpitis for pulp therapy enrolled voluntarily to the study since 2012 to 2013. They should not have any history of taking any medication that would alter the inflammatory response of the pulp or provide analgesia for the previous 14 days. Any history of alergy to anesthetic solutions causes to exclusion of the patient. Patients divided to two groups randomly. For the case group, primary pulpal anesthesia will provide with Intra Osseous injection of Mepivacaine 3%. For the control group, primary pulpal anesthesia will provide with Inferior Alveolar Nerve Block injection of Mepivacaine 3%. Effect onset of anesthesia, persistence of anesthesia, degree of pain during pulp therapy and blood pressure changes after anesthesia injection will be evaluated and the results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022712634N1
Registration date:2013-12-25, 1392/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
Maryam Shafeie
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1225 0312
Email address
hamidrazavian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-10-05, 1391/07/14
Expected recruitment end date
2013-10-06, 1392/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Success Rate of Inferior Alveolar Nerve Block versus IntraOsseous Injection For Pulpal Anesthesia in The Posterior Mandibular Teeth with Irreversible Pulpitis in patients attending to Afzal dental clinic, Isfahan, Iran 1391-92
Public title
Comparison of Anesthesia Success Rate in Mandibular Inflammatory Tooth Between two Different Injection Techniques
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Patients with at least one posterior mandibular tooth with irreversible pulpitis for pulp therapy that each pulp therapy would be appliable thoroughly in one visit;
2) No history of taking any medication that would alter the inflammatory response of the pulp or provide analgesia for the previous 14 days;
3) No history of major systemic or cardiovascular disease;
4) Patients aged 18 to 65 years old;
5) Absence of acute inflammation and advanced periodontal disease at the injection area;
6) Provision written informed consent;
Exclusion criteria:
1) Any history of alergy to anesthetic solutions;
2) lack of cooperation or interest of patient to continue the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Isfahan University of Medical Sciences
Street address
Building number 4, Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Postal code
Approval date
2012-06-12, 1391/03/23
Ethics committee reference number
391473
Health conditions studied
1
Description of health condition studied
tooth with irreversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
Pulpitis: NOS acute chronic (hyperplastic)(ulcerative) irreversible reversible
Primary outcomes
1
Description
Success of the Anesthesia
Timepoint
After the Injection and during root canal therapy (RCT)
Method of measurement
Vitality pulp test (pulp tester and endo ice) before RCT and questioning from patients during RCT
2
Description
Pain
Timepoint
During injection of Anesthetic solution
Method of measurement
Heft-parker visual Analogue Scale
3
Description
Blood Pressure
Timepoint
Before and After Anesthetic injection
Method of measurement
Digital indicator -mmhg
4
Description
Onset of Anesthesia
Timepoint
After the injection with 1-minute intervals for a period of 15 minutes
Method of measurement
Vitality pulp test (pulp tester and endo ice)
5
Description
Duration of Anesthesia
Timepoint
From the beginning to the end of RCT
Method of measurement
Asking from the patients
Secondary outcomes
1
Description
Hematoma
Timepoint
One hour after the injection
Method of measurement
Observation
Intervention groups
1
Description
For the first group, primary pulpal anesthesia will provide with Intra Osseous injection of Mepivacaine 3%
Category
Treatment - Other
2
Description
For the second group, primary pulpal anesthesia will provide with Inferior Alveolar Nerve Block injection of Mepivacaine 3%
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzal dental clinic
Full name of responsible person
Razavian Seyyedhamid
Street address
Afzal dental clinic, Soroosh ave, Ahmad Abad Square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Vice chancellor for research, Building number 4 , central organ of university, Isfahan university of medical science, Hezar Jarib Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shafeie Maryam
Position
Student of dentistry
Other areas of specialty/work
Street address
No 33, Shahid Hamidii alley, Bozorgmehr ave, Ahmadabad Square
City
Isfahan
Postal code
Phone
+98 31 1226 3421
Fax
Email
marymahsash@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shafeie Maryam
Position
Student of dentistry
Other areas of specialty/work
Street address
No 33, Shahid Hamidi alley, Bozorgmehr ave, Ahmadabad square
City
Isfahan
Postal code
Phone
+98 31 1226 3421
Fax
Email
marymahsash@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Shafeie Maryam
Position
Student of dentistry
Other areas of specialty/work
Street address
No 33, Shahid Hamidi alley, Bozorgmehr ave, Ahmadabad sqare
City
Isfahan
Postal code
Phone
+98 31 1226 3421
Fax
Email
marymahsash@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)