The effect of mental nerve block with pressure along with inferior alveolar nerve block on root canal treatment of mandibular first molars with asymptomatic irreversible pulpitis: a triple blind randomized clinical trial
Study aim: evaluation of the effect of mental nerve block(MNB) with pressure following inferior alveolar nerve block (IANB) on anesthetic success of first mandibular molars with asymptomatic irreversible pulpitis. Study design: clinical trial,randomized, triple blind, non-controlled with placebo, single center, phase 3 of trial. Table of random numbers is used for randomization in this study. Target population of the study: patients referring to Endodontics Department of Tabriz Dental Faculty for root canal treatment in 2016-2017. Main inclusion criteria: mandibular first molars with asymptomatic irreversible pulpitis and normal periapical radiography appearance without sensitivity to percussion. Exclusion criteria: patients with tooth pain at the time of study. Sample size is 70(35 per group). Interventions of this study: In both groups, after injection of a standard IANB using 1.8 ml 2% lidocaine with 1:100000 epinephrine, a standard MNB including 1.8 ml 2% lidocaine with 1:100000 epinephrine will be given by an operator not involved in assessing the outcomes.After injection, in group 1(active treatment) the patient will apply firm fingers pressure on the soft tissue of mental foramen region for 1 minute with opposite hand and in group 2 (control treatment) the pressure will be applied on the crowns of premolar teeth. Primary outcome: Degree of electric pulp tester response (before and after intervention)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090329671N1
Registration date:2016-10-21, 1395/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-21, 1395/07/30
Registrant information
Name
Amir Ardalan Abdollahi
Name of organization / entity
Department of Endodontics, Faculty of Dentistry,Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 8174
Email address
samieim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mental nerve block with pressure along with inferior alveolar nerve block on root canal treatment of mandibular first molars with asymptomatic irreversible pulpitis: a triple blind randomized clinical trial
Public title
Anesthesia efficiency of mental nerve block with pressure along with inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Healthy adults aged from 18 to 55 years; mandibular first molars with asymptomatic irreversible pulpitis and normal periapical radiography appearance without sensitivity to percussion. Clinical diagnosis of tooth with irreversible pulpitis will be confirmed by positive response to electric pulp tester (PARKELL, PT-20, USA) and a lingering exaggerated response (>10 seconds) with moderate-to-severe pain to cold test after the cotton pellet removal.
Exclusion criteria: systemic disease; patients with tooth pain at the time of study; unstable heart disease; known allergy to local anesthetic agents of lidocaine 2% with 1/80000 epinephrine or latex; patients taking sedatives; oral/facial paresthesia; use of analgesics and anxiety medications for 12 hours before the treatment or any other drugs; symptomatic irreversible pulpitis cases; presence of periapical radiolucency; pregnancy; breast-feeding; non-repairable tooth and presence of crown.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers is used for randomization in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz
City
Tabriz
Postal code
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TBZMED.REC.1395.485
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
degree of electric pulp tester response
Timepoint
before and after local anesthesia injection
Method of measurement
Electric pulp tester(EPT)
Secondary outcomes
1
Description
pain intensity
Timepoint
During initial stages of root canal treatment(access cavity preparations)
Method of measurement
visual analoge scale
Intervention groups
1
Description
In both groups, after injection of a standard inferior alveolar nerve block using 1.8 ml 2% lidocaine with 1:100000 epinephrine, a standard mental nerve block including 1.8 ml 2% lidocaine with 1:100000 epinephrine will be given within 60 seconds by an operator not involved in assessing the outcomes.After injection, in group 1(active treatment) the patient will apply firm fingers pressure on the soft tissue of mental foramen region for 1 minute with opposite hand.
Category
Treatment - Drugs
2
Description
In both groups, after injection of a standard inferior alveolar nerve block using 1.8 ml 2% lidocaine with 1:100000 epinephrine, a standard mental nerve block including 1.8 ml 2% lidocaine with 1:100000 epinephrine will be given within 60 seconds by an operator not involved in assessing the outcomes.After injection, in group 2(control treatment) the patient will apply the pressure on the crowns of premolar teeth for 1 minute with opposite hand.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Endodontics, Dental faculty
Full name of responsible person
Dr.Shahriar Shahi, Endodontist, Professor
Street address
Second floor, Entry 3, Dental Faculty, Daneshgah Avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
Second floor, Entry number 2, Tabriz dental faculty, Daneshgah Avenue, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Tabriz 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
Department of Endodontics, Faculty of Dentistry
Full name of responsible person
Amir Ardalan Abdollahi
Position
Postgraduate student of Endodontics, Dentist
Other areas of specialty/work
Street address
Second floor, Entry 3, Dental Faculty, Daneshgah Avenue, Tabriz