Protocol summary

Summary
The purpose of this prospective, randomized, double-blind clinical study is to compare the efficacy of inferior alveolar nerve block (IANB), IANB with buccal infiltration and modified antraseptal injection of articaine in mandibular molars with irreversible pulpitis. Ninety healthy patients with the diagnosis of symptomatic irreversible pulpitis and normal periapical in mandibular molars will participate in this study and allocate randomly in three groups. The patients are asked to rate their pain on VAS after using cold test (VAS1). The teeth also are tested using electrical pulp tester (EPT1). In first group patient will receive standard IANB injection using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine. In the second group they will be administrated standard IANB using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine and buccal infiltration using 1.8 ml of 4% articaine with 1:100,000 epinephrine. In the third group, the patient will receive modified intraseptal using 1.8 ml of 4% articaine with 1:100,000 epinephrine. The injection of 1 ml anesthetic solution in the buccal vestibule and 0.8 ml of anesthetic solution in the mesial and distal dental papilla is considered as modified intraseptal . All injections will be done by a single operator. After 10 minutes, the pulpal anesthesia will be measured by electrical pulp tester (EPT2), then the access cavity will be prepared. If patients do not report lip numbness 10 minutes after IANB injection, they exclude from the study. Patients will be instructed to rate any discomfort during access on the Heft-Parker visual analogue (VAS2) scale. The success of anesthesia are defined as reading EPT ≥80 and the ability to access the tooth with no or mild pain (VAS ≤54).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015073023412N1
Registration date: 2017-10-15, 1396/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Omid Dianat
Name of organization / entity
Dental School of Shahid Beheshti University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
omiddianat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Inferior alveolar nerve block (IANB), IANB along with buccal infiltration and modified intraseptal of Articaine in mandibular molars affected with irreversible pulpitis
Public title
The efficacy of three different anesthetic technique in mandibular molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy patients; aged 18 to 65 years; No allergy to lidocaine or articaine with 1:100,000 epinephrine; No pregnancy; having mandibular molars teeth with irreversible pulpitis and normal periapical radiographic appearance; Clinical diagnosis of irreversible pulpitis was confirmed by a positive response to an electric pulp test and a prolonged response with moderate to severe pain to a cold test using Roeko Endo-Frost . Exclusion criteria: presence of periodontal ligament (PDL) widening or periapical radiolucency; recently taken nervous system depressant or analgesic medication within 12 hours before treatment; absence of vital coronal pulp tissue during access preparation; failure to report lip numbness 10 minutes after Inferior alveolar nerve block injection.
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random number table will use for randomization patients and clinician who record the results do not aware of type of intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Shahid Behsheti University of Medical Science
Street address
Daneshju Blv. Evin Blv. Chamran highway
City
Tehran
Postal code
1983963113
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
ir.sbmu.rids.rec.1394.77

Health conditions studied

1

Description of health condition studied
pulpitis
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues, irreversible pulpitis

Primary outcomes

1

Description
pain
Timepoint
Befor intervention and 10 minutes after intervention
Method of measurement
Heft- parker Visual analog scales

Secondary outcomes

1

Description
Pulp sensivity
Timepoint
Before injection and 10 minutes after injection
Method of measurement
Electerical pulp test

Intervention groups

1

Description
group I: inferior alveolar nerve block (IANB) injection of 1.8 ml of 2% lidocaine with epinephrin 1;100000
Category
Treatment - Drugs

2

Description
group II: inferior alveolar nerve block injection of 1.8 ml lidocaein 2% with epinephrin 1:100000 and buccal infiltration of 1.8 ml articaine 4% with epinephrin 1:100000
Category
Treatment - Drugs

3

Description
group III: intraseptal injection of 0.8 ml articaine 4% with epinephrine 1:100000 and bucal infiltration of 1ml articaine 4% with epinephrine 1:100000
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Omid Dianat
Street address
Daneshju Blv, Evin St,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Rezghi
Street address
Daneshju Blv. Evin. Chamran highway
City
Tehran
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, Shahid Beheshti 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
Dental School of Shahid Beheshti University of Medical Science
Full name of responsible person
Dr Omid Dianat
Position
Associated professor
Other areas of specialty/work
Street address
Dental school, Shahid Beheshti University,Daneshju Blv. Evin Blv. Chamran highway
City
Tehran
Postal code
Phone
+98 21 2240 3075
Fax
Email
omiddianat@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences,Dental school
Full name of responsible person
Dr Omid Dianat
Position
Associated Professor
Other areas of specialty/work
Street address
Dental school, Shahid Beheshti University,Daneshju Blv, Evin Blv, Chamran Highway,
City
Tehran
Postal code
Phone
+98 21 2240 3010
Fax
Email
omiddianat@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental School, Shahid Beheshti University of Medical Sience
Full name of responsible person
Shiva Shojaeian
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshju Blv, Evin, Chamran Highway
City
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Fax
Email
shiva.shojaeian@gmail.com
Web page address

Sharing plan

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