Protocol summary

Summary
This study was to compare the success rate of using both an IAN block and a buccal infiltration and periodontal injection with that obtained by using an IAN block alone for endodontic treatment of mandibular teeth with irreversible pulpitis. In a randomized double-blinded clinical Trial, eighty-six patients were randomly assigned to 2 groups of 43 patients each. The exclusion criteria are the presence of systemic disorders, a sensitivity to lidocaine with 1:80,000 epinephrine, a sensitivity to NSAIDs and the Inclusion criteria included healthy patients having a first mandibular molar tooth with irreversible pulpitis and normal periapical radiographic appearance. Lidocaine 2% with 1:80,000 epinephrine was used for all injections. Group I patients received an IAN block with 3.6 mL of anesthetic. Group II patients received 1.8 mL as an IAN block and 1.8 mL as a buccal infiltration and after 15 minuets received 0.9 ml periodontal injection . A visual analogue scale was used to rate pain before anesthesia and discomfort experienced before and during access cavity preparation. Data were analyzed by Tow way repeated measure ANOVA, multivariate logistic regression.

General information

Acronym
Inferior alveolar nerve blok (IANB)
IRCT registration information
IRCT registration number: IRCT138901072016N4
Registration date: 2012-05-13, 1391/02/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-13, 1391/02/24
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of combining variuse anesthesia technique in success rate of anesthesia in first mandibular molar with irreversible pulpitis
Public title
Efficacy of combining variuse anesthesia technique in success rate of anesthesia in inflammaded posterior tooth of mandible
Purpose
Treatment
Inclusion/Exclusion criteria
The exclusion criteria were the presence of systemic disorders, a sensitivity to lidocaine with 1:80,000 epinephrine, a sensitivity to NSAIDs, the presence of widening of the periodontal ligament space, the presence of a periapical radiolucency, lactation, pregnancy. Inclusion criteria included healthy patients having a first mandibular molar tooth with irreversible pulpitis and normal periapical radiographic appearance, whit out spontaneously pain that to be needed emergency treatment.
Age
From 18 years old to 83 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
vice president for research building;kerman university of medical sciense
Street address
somaye cross road;vice president for research building;kerman university of medical sciense
City
kerman
Postal code
Approval date
2012-02-04, 1390/11/15
Ethics committee reference number
KA/90/336

Health conditions studied

1

Description of health condition studied
irreversible pulpitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain degree
Timepoint
Befor and after intervention
Method of measurement
Visual Analogous Scale(VAS)

Secondary outcomes

1

Description
Pain in the location of injection
Timepoint
24 and 48 houre after treatment
Method of measurement
Visual analogous scale

Intervention groups

1

Description
Inferior alveolar nerve block injection
Category
Treatment - Other

2

Description
Inferiore alveolar nerve block injection, buccal infilteration and peridontal injection
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Sciences,school of dentistry
Full name of responsible person
Street address
Jomhori Eslami Bloubvared, Headquarter Builidng of Kerman Medical Sciences University
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice president for research building;kerman university of medical sciense
Full name of responsible person
masoud parirokh
Street address
somaye cross road ,vice president for research building;kerman university of medical sciense
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice president for research building;kerman university of medical sciense
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
Kerman University of Medical Sciences
Full name of responsible person
saeede sadr
Position
resident of endodontics
Other areas of specialty/work
Street address
Jomhori Eslami Bloubvared, Headquarter Builidng of Kerman Medical Sciences University
City
kerman
Postal code
Phone
+98 34 1281 5388
Fax
Email
sadrsaeede@yahoo.com891233001@collegian.kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
masoud parirokh
Position
endodontics
Other areas of specialty/work
Street address
Jomhori Eslami Bloubvared, Headquarter Builidng of Kerman Medical Sciences University
City
kerman
Postal code
Phone
+98 34 1245 7931
Fax
+98 34 1211 8073
Email
masoudparirokh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
saeede sadr
Position
resident of endodontics
Other areas of specialty/work
Street address
بلوار جهوری اسلامی- سازمان مرکزی دانشگاه علوم پزشکی
City
kerman
Postal code
Phone
+98 34 1281 5388
Fax
Email
sadrsaeede@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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