Objectives: The aim of this study is to assess the efficacy of Gow-Gates and inferior alveolar nerve block on success rate of anesthesia in patients with irreversible pulpitis.
Design: Prospective, randomized, double blind study
Setting and conduct: Forty patients with including criteria who failed to infra alveolar nerve block will be randomly divided into two groups on a random basis and will receive Gow-Gates or another inferior alveolar nerve block injection. Their pain will be evaluated by electric pulp tester every 5 minutes for two times. Endodontic access cavity preparation will be initiated after complete anesthesia. If patients feel any pain during the Endodontic access cavity preparation or canal instrumentation treatment will be stopped and their pain will be measured by Visual Analog Scale. The patients will be instructed to rate any pain during each step of access cavity preparation, within dentin, and when a file is being inserted into the root canals. The data will be analysed by Mann-U-Whitney and CHI- SQUARE tests.
Participants including major eligibility criteria:Patients with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54); without systemic diseases; non smoking and analgesic/sedative consumption who receive one conventional inferior alveolar nerve block and their block is failed ( without lip numbness ).
Intervention: Gow Gates or Infra Alveolar Nerve Block injection.
Main outcome measures (variables): The rate of pain during each step of access cavity preparation, within dentin, and when a file is being inserted into the root canals will be measures based on visual analog scale following Gow-Gates /infra alveolar nerve block injections.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030516845N1
Registration date:2015-06-30, 1394/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-30, 1394/04/09
Registrant information
Name
Nahid Akhlaghi
Name of organization / entity
Tehran Dental Branch Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2201 1751
Email address
n_akhlaghi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigaror
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Gow-Gates and Inferior alveolar nerve block on success rate of anesthesia in patients with symptomatic irreversible pulpitis
Public title
Comparative efficacy of two injection methods on success rate of dental anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients with age ranged 18-65; without systemic diseases ; without any medicine consumption; non smoking; non pregnant; non breast feeding; with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54); failed to anesthesia after receiving one conventional infra alveolar nerve block ( without lip numbness )
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:
40
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
Ettics committee of Islamic Azad University, Tehran dental Branch
Street address
Pasdaran Ave,10th Neyestan
City
Tehran
Postal code
19468
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
D/266/P
Health conditions studied
1
Description of health condition studied
Patients without systemic diseases or medicine consumption
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anesthesia following the injection
Timepoint
5 Minutes
Method of measurement
Electric pulp tester and cold test
Secondary outcomes
1
Description
Root Canal treatment without pain
Timepoint
Caries removal, access cavity preparation and canal preparation procedures
Method of measurement
Pain rate based on VAS
Intervention groups
1
Description
Gow-Gates injection with one dose 1.7 mL Articaine 4% with adrenaline 1/100,000
Category
Treatment - Drugs
2
Description
Infra Alveolar Nerve Block injection with one dose 1.7 mL Articaine 4% with adrenaline 1/100,000
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Street address
Pasdaran Ave, 10th Neyestan
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for Research,Dental Branch Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
no 4, 10th neyestan
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for Research,Dental Branch Islamic Azad University
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 University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor /DDS,MS
Other areas of specialty/work
Street address
Pasdaran Ave.10th Neyestan
City
Tehran
Postal code
19468
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor/DDS,MS
Other areas of specialty/work
Street address
Pasdaran Ave,10th Neyestan
City
Tehran
Postal code
19468
Phone
+98 21 2201 1751
Fax
+98 21 2201 1932
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor/DDS,MS
Other areas of specialty/work
Street address
Pasdaran ave,10th Neyestan
City
Tehran
Postal code
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)