Effect of supplementary infiltration injection of Sodium Bicarbonate on success rate of IANB of mandibular first molars with irreversible pulpitis: A Randomized, Clinical, Double-blind Study
The aim of this single-center phase 2 prospective , randomized, double-blind clinical trial, is to investigate effect of sodium bicarbonate injection infiltration on inferior alveolar nerve block success rate in teeth with irreversible pulpitis compared to infiltration injection of sterile water as placebo in the same teeth.
100 healthy patients over 18 years old that do not take any medication with diagnosis of symptomatic irreversible pulpitis in mandibular first molar teeth by use of cold test were selected.Patients and physician were blind about liquid in infiltration injection were drug or placebo therefore the study considered as a double-blind study. In the first group (Group buffer) before the mandibular alveolar nerve block injection, 0.7 ml of sodium bicarbonate with 0.3 ml of 8.4% lidocaine (to reduce pain during injection) measured by use of a Hamilton syringe injected as an supplementary infiltration injection to distal of first molar. The same amount of distilled water and Lidocaine used in placebo group. After 15 minute if lip numbness not happened in patient 3.8 ml of lidocaine injected as inferior alveolar nerve block. Success defines as no or mild pain according to Heft-Parker visual analog scale (VAS).
General information
Acronym
IANB=inferior alveolar nerve block
IRCT registration information
IRCT registration number:IRCT201409142541N4
Registration date:2016-05-24, 1395/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-24, 1395/03/04
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
Isfahan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplementary infiltration injection of Sodium Bicarbonate on success rate of IANB of mandibular first molars with irreversible pulpitis: A Randomized, Clinical, Double-blind Study
Public title
Effect of sodium bicarbonate on success of inferior alveolar anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18 years of age and over; being in good health condition;having a mandibular first molar tooth with symptomatic irreversible pulpitis;not having periodontal problem; normal periapical radiographic appearance (other than a widened periodontal ligament); and normal periapical radiographic appearance (other than a widened periodontal ligament); no history of allergy
Exclusion criteria: History of any systemic disorders, lactation, pregnancy, allergy to Local anesthesia, taking any medications that might influence anesthetic assessment, presence of periradicular radiolucency, swelling or having fistula near target tooth, active sites of pathosis in area of injections, or any problem that patient could not give informed consent; lack of lip numbness within 15 minutes after mandibular alveolar nerve block injection
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
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
Used
Assignment
Single
Other design features
Patients and physician were unaware that liquid in infiltration injection were drug or placebo therefore the study considered as a double-blind study.
Secondary Ids
1
Registry name
ClinicalTrials.gov ID: NCT02726737
Secondary trial Id
941234
Registration date
2016-04-01, 1395/01/13
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
2016-02-04, 1394/11/15
Ethics committee reference number
IR.MUI.REC.1394.3.1020
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
Pain
Timepoint
Before treatment and after initiating root canal therapy
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 recording of pain
Intervention groups
1
Description
infiltration injection involved 0.7 ml of distilled water and 0.3 ml of 2% lidocaine with 1.80000 epinephrine
Category
Placebo
2
Description
infiltration injection involved 0.7 ml of sodium bicarobonate and 0.3 ml of 2% lidocaine with 1.80000 epinephrine
Category
Treatment - Drugs
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
81746-7346
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
81746-7346
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
+98 31 3792 2822
Fax
Email
saatchi@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)