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Comparison of anesthetic efficacy lidocain / epinephrine with and without sufentanil for intra ligamentary injection in the mandibular posterior tooth with irreversible pulpitis

Protocol summary

Summary
The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in irreversible pulpitis teeth. Qualified individuals were selected among people referred to the endodontic part of Azad University of Tehran; the study was conducted with a double blind placebo control clinical trial. 60 patients between 18-65 years of age, which had mandibular posterior teeth in clinical diagnosis with irreversible pulpitis, received injections of normal alveolar block. In all those who had numbness around the lips, maximum output response to pulp testing, 15 minutes after receiving infra alveolar block, it was performed the starting of preparing the cavity, and those who had moderate to severe pain, were injected with intra ligaments supplements. They reported their pain with Visual Analogue scale(Vas), before the injection, immediately after injection, access cavity, Pulpotomy and putting the initial file and pulpectomy. The volunteers were divided randomly in to two groups namely control group (lidocaine/epinephrine) and case group (combined solution of lidocaine/epinephrine & sufentanil). The injection was done by 0.5-inch and 27 needle gauge which was connected to the pressure syringes. Injection sites were on mesiobuccal and Disto buccal location. Depth of anesthesia was recorded by electric pulp tester (EPT) in 1 and 5, 9, 13 and 17 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110137790N1
Registration date: 2012-01-25, 1390/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-25, 1390/11/05
Registrant information
Name
Hengameh Mohammadi
Name of organization / entity
Dentistry Azad Univercity of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 3426
Email address
peymanm@dentliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad dental university of Tehran
Expected recruitment start date
2010-10-14, 1389/07/22
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthetic efficacy lidocain / epinephrine with and without sufentanil for intra ligamentary injection in the mandibular posterior tooth with irreversible pulpitis
Public title
Effect of sufentanil on the severe of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with VITAL mandibular molars; patients with dental with irreversible pulpits clinical evidence; those candidates who suffer from moderate to severe pain; patients who signed consent form; those who felt with lip edge anesthesia after injection of infra alveolar (INA) and those who responded positively to output maximum of pulp tester. Exclusion criteria: Systemic disease; pregnancy and lactation; age: Patients under the age of 18 years and older than 65 years; infectious diseases; moderate to advanced periodontal disease; necrotic teeth; sensitivity OPIOIDs, Benzodiazepines, Barbiturate or use of them in the past 48 hours; those without lip edge anesthesia after injection of infra alveolar (INA), and those, does not respond to maximum output pulp tester after injection of INA.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad dental university of Tehran
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
18081

Health conditions studied

1

Description of health condition studied
irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
intensity of the pain
Timepoint
before intervention,during the intervention,in the immediately after injection,access cavity,initial file,pulpotomy,pulpectomy
Method of measurement
with visual analogue scale(VAS)

2

Description
depth of anesthesia
Timepoint
before intervention,during the intervention,in the 1,5,9,13,17th minuths
Method of measurement
with electric pulp tester

Secondary outcomes

empty

Intervention groups

1

Description
second group:0/4 ml lidocain with epinephrine and0/4 ml sufentanil ( 0/04 μg)
Category
Treatment - Drugs

2

Description
first group:0/4 ml lidocain %2 with epinephrine,0/4 ml salin
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad dental Univercity of Tehran
Full name of responsible person
Dr. Peyman Mehrvarz far
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad dental university of Tehran
Full name of responsible person
Dr. Arash Azizi
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad dental university of Tehran
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
Islamic Azad dental university of Tehran
Full name of responsible person
Dr. Peyman Mehrvarz far
Position
Associate Professor
Other areas of specialty/work
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
اpeymanm@dentliau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad dental Univercity of Tehran
Full name of responsible person
Peyman Mehrvarz far
Position
assosiate professor
Other areas of specialty/work
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
اpeymanm@dentliau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad dental university of Tehran
Full name of responsible person
Dr. Peyman Mehrvarz far
Position
Associate Professor
Other areas of specialty/work
Street address
Islamic Azad university, dentistry department, 10th neistan, Pasdaran
City
Tehran
Postal code
Phone
Fax
Email
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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