Anesthetic Efficacy of Gow-Gates Nerve Block, Inferior Alveolar Nerve Block, and Their Combination in Mandibular Molars in Patient with Symptomatic Irreversible Pulpitis
The aim of this phase 3 prospective randomized clinical trial, was to evaluate the anesthetic efficacy of Gow-Gates nerve block (GGNB), inferior alveolar nerve block (IANB), and their combination for mandibular molars in patients with symptomatic irreversible pulpitis . One hundred fifty healthy patients over 18 years old that do not take any medication within 24 hours before the treatment with diagnosis of symptomatic irreversible pulpitis in mandibular molar tooth by use of cold test were selected.The patients randomly received two cartridge of 1.8 mL 2% lidocaine with 1:80,000 epinephrine by two GGNB injections or two IANB injections or one GGNB injection plus one IANB injection. Access cavity preparation was initiated 15 minutes after injections. Lip numbness was a requisite for all the patients. Success was specified as no or mild pain on the basis of Heft-Parker visual analog scale recordings during access cavity preparation or initial instrumentation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705092541N5
Registration date:2017-07-10, 1396/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-10, 1396/04/19
Registrant information
Name
Masoud Saatchi
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2822
Email address
saatchi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anesthetic Efficacy of Gow-Gates Nerve Block, Inferior Alveolar Nerve Block, and Their Combination in Mandibular Molars in Patient with Symptomatic Irreversible Pulpitis
Public title
Anesthetic Efficacy of Gow-Gates Nerve Block, Inferior Alveolar Nerve Block, and Their Combination in Mandibular Molars in Patient with Symptomatic Irreversible Pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Eighteen years of age and over; being in good health condition; having a mandibular first molar tooth with symptomatic irreversible pulpitis; not having severe periodontal problem; normal periapical radiographic appearance (other than a widened periodontal ligament); no history of allergy to local anesthesia or sulfite
Exclusion criteria: pregnancy; lactation; taking any medications that might influence anesthetic assessment; swelling or having fistula near target tooth; active sites of pathosis in area of injection; any problem that patient could not give informed consent; lack of lip numbness within 15 minutes after injection
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176.
City
Isfahan
Postal code
8174673461
Approval date
2017-02-03, 1395/11/15
Ethics committee reference number
IR.MUI.REC.1395.3043
Health conditions studied
1
Description of health condition studied
irriversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis: NOS acute chronic (hyperplastic)(ulcerative) irreversible reversible
Primary outcomes
1
Description
Initial pain
Timepoint
Before treatment
Method of measurement
Heft-Parker Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Post pain
Timepoint
During procedure
Method of measurement
Heft-Parker Visual Analog Scale
Intervention groups
1
Description
The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:180,000 epinephrine
Category
Treatment - Other
2
Description
The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:80,000 epinephrine
Category
Treatment - Other
3
Description
The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:80,000 epinephrine
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Endodontics, Dental School, Isfahan
Full name of responsible person
Masoud Saatchi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
Isfahan
Postal code
Phone
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
Isfahan
Postal code
Phone
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Masoud Saatchi
Position
Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)