Objectives,the aim of this study will comparing the effect of supplementary buccal and/or lingual articaine infiltration after inferior alveolar nerve block success rate in symptomatic irriversible pulpitis (2) Design (study groups and phase, sample size, blinding, randomization, single or multi center: randomized clinical trial,double blind,160 samples,single center (3) Setting and conduct:these samples will randomly divided to 4 groups(3 intervention, one control). (4) Participants including major eligibility criteria:healthy patients between 18 to 65 years old,male or female have one molar with irriversible pulpitis included in this study( totally 160 person). (5) Intervention:endodontic access preparation will initiate after injections and pain during treatment will record. (6) main outcome measures (primary and secondary outcome variables): intensity of pain(0-170)will record.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112715782N3
Registration date:2016-04-26, 1395/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Peyman Mehrvarzfar
Name of organization / entity
Tehran Medical Science Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8875 9644
Email address
p_mehrvarzfar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of supplementary buccal and/or lingual articaine infiltration on inferior alveolar nerve block success rate in symptomatic irreversible pulpitis.
Public title
Comparing the effect of supplementary injection on inferior alveolar nerve block success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients between 18 to 65 years old; without any systematic disease or drug using; no allergic reaction to the anesthetic; no smoking; not using analgesic 24 hours ago; no pregnant or breastfeeding and they must have one molar with irreversible pulpitis.
Exclusion criteria: pulp necrosis; periapical radioluscency.
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:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers will use for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Medical Science Branch,Islamic Azad University
Street address
No.4,Neyestan 10 Alley,Pasdaran Street
City
Tehran
Postal code
19585/175
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
AZadUMS-94/P/166/D
Health conditions studied
1
Description of health condition studied
irriversible pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
15 minute after injection
Method of measurement
Heft Parker visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: block injection with articaine buccal infiltration
Category
Treatment - Other
2
Description
intervention group 2: block injection with articaine lingual infiltration
Category
Treatment - Other
3
Description
intervention group 3: block injection with articaine buccal and lingual infiltration
Category
Treatment - Other
4
Description
control group: block injectin without any supplementary injectoin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Medical Science branch,Islamic Azad University
Full name of responsible person
Peyman Mervarzfar
Street address
No.4,Neyestan 10 Alley,Pasdaran Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
Peyman Mehrvarzfar
Street address
Tehran medical science branch,Islamic azad university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Tehran Medical Science Branch,Islamic Azad University
Full name of responsible person
Setareh Ghannad
Position
Endodontic Resident/ DDS
Other areas of specialty/work
Street address
No.4, Neyestane 10 Alley,Pasdaran Street
City
Tehran
Postal code
19585/175
Phone
+98 21 8868 1285
Fax
+98 21 8875 9644
Email
Ghannad.setareh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Science Branch/Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate Professor/ DDS,Ms
Other areas of specialty/work
Street address
No.4,Neyestan 10 Alley,Pasdaran Street
City
Tehran
Postal code
Phone
+98 21 8875 9644
Fax
Email
P_mehrvarzfar@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Medical Science Branch,Islamic Azad University
Full name of responsible person
Setareh Ghannad
Position
Endodontic Resident/ DDS
Other areas of specialty/work
Street address
No.4, Neyestan 10 Alley,Pasdaran Street
City
Tehran
Postal code
19585/175
Phone
+98 21 8868 1285
Fax
+98 21 8875 9644
Email
ghannad.setareh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)