Comparison of the anesthetic efficacy of Articaine 4% as supplemental Intraligamentary injection with Buccal Infiltration in posterior mandibular teeth with irreversible pulpitis
Our aim is the Comparison of the anesthetic efficacy of Articaine 4% as supplemental Intraligamentary injection with Buccal Infiltration in posterior mandibular teeth with irreversible pulpitis. 100 patients in Shahid Beheshti Endodontics ِDepartment will be participated in this study. All the patients should have first or second vital mandibular molar without spontanous pain and should have positive response to Electrical Pulp Tester and prolonged response to cold test. We will record patients pulses before the treatment. All the patients will receive Inferior Alveolar Nerve Block with 1.5 ml Lidocaine 2% with epinephrine 1/100000 and 0.3 ml long buccal injection with Lidocaine 2% with epinephrine 1/100000. After 15 minutes the patients without lip numbness will be excluded. The teeth will be examined by cold test and Electrical Pulp Tester and the patients indicate their pain on Heft Parker Visual Analogue Scale and the pain will be record like this in all stages. The pulse after the Inferior Alveolar Nerve Block injection will be recorded. If the Electrical Pulp Test number after this injection will be under 80 we will consider supplemental injection. All the injections will be done by one person. After 5 minutes the teeth will be examined by cold test and Electrical Pulp Tester and the patients will indicate their pain and the pulse will be recorded and the access cavity will be prepared and initial filing will be done. If the patients report moderate to severe pain during these procedures another anesthetic technique will be considered for them and will be reported as a failure. The patients will be classified randomly into 2 subgroups. In subgroup 1, 0.4 ml of the Intraligamentary injection with Articaine 4% with epinephrine 1/80000 and in subgroup 2, 1.8 ml of the Buccal Infiltration injection with Articaine 4% with epinephrine 1/80000 will be performed. Another person should fill the questionnaire, this person and the patients are blind to the injection technique.The success of 2 injections is considered to the ability for preparing the access cavity completely and initial filing without any pain or mild pain.
General information
Acronym
PDL: Periodontal ligament
IRCT registration information
IRCT registration number:IRCT2015072023253N1
Registration date:2016-08-17, 1395/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-08-17, 1395/05/27
Registrant information
Name
Nazanin Zargar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
n.zargar48@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the anesthetic efficacy of Articaine 4% as supplemental Intraligamentary injection with Buccal Infiltration in posterior mandibular teeth with irreversible pulpitis
Public title
Comparison of the anesthetic efficacy of Articaine 4% in two supplemental anesthetic injections
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients older than 18 without any systemic diseases, first or second mandibular molars with irreversible pulpitis, no pre apical lesion in radiography, prolonged response with moderate to saver pain to cold test and check the vitality by Electrical Pulp Tester, vital coronal pulp tissue
Exclusion criteria: systemic disease, allergic response to Lidocaine or Articaine, pre apical lesion or pre apical radiolucency, lactate or pregnant women, using analgesic drugs since 12 hours before the treatment, mobility more than 5mm, probing more than 3mm in mesial and distal, severe dental pain needs emergency treatment, nonvital coronal pulp tissue, teeth with full crowns
Exclusion criteria after the treatment: no lip numbness after the Inferior Alveolar Nerve Block injection, no pulp exposure after removing caries, no bleeding while pulp exposure
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Shahid Beheshti University of Medical Sciences
Street address
Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.24
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
Anesthesia
Timepoint
After Inferior alveolar Nerve Block injection, After supplemental injection
Method of measurement
Electrical Pulp Tester
2
Description
Pulse
Timepoint
Before Inferior Alveolar nerve Block injection, After Inferior alveolar nerve Block injection, After supplemental injection
Method of measurement
Pulse-Oximetre
3
Description
Pain during injection
Timepoint
During Inferior Alveolar Nerve Block and supplemental injection
Method of measurement
Heft Parker Visual Analogue Scale
4
Description
Pain
Timepoint
After Inferior Alveolar Nerve Block and supplemental injection
Method of measurement
Heft Parker Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
After Inferior Alveolar Nerve Block injection with Lidocaine and Epinephrine 1/80000, the supplemental Buccal Infiltration injection with Articaine 4% and Epinephrine 1/100000 will be done
Category
Treatment - Other
2
Description
After Inferior Alveolar Nerve Block injection with Lidocaine and Epinephrine 1/80000, the Intraligamentry injection with Articaine 4% and Epinephrine 1/100000 will be done
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Behsehti University of Medical Sciences
Full name of responsible person
Dr. Zarghi
Street address
Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Behsehti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
nzargar48@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Zargar
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental school of Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Evin Ave, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 219121328143
Fax
Email
nzargar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)