Evaluation of effect of adding Dexmedetomidine to Lidocaine in success of inferior alveolar nerve block in patients with asymptomatic irreversible pulpitis
Comparing the effect of adding Dexmedetomidine to Lidocaine with plain Lidocaine in success of Inferior Alveolar Nerve block in patients with asymptomatic irreversible pulpitis.
An endodontist operates injections to the patients referred to Endodontic department of dental branch of Tehran Islamic Azad University .
Operator and patients are blinded.
Randomized block.
Participants/Inclusion and exclusion criteria
patients having a tooth with asymptomatic irriversible pulpitis
ASA class I,II.
not pregnant/ in lactation.
not smoking and not addicted.
not using psychologic drugs.
haven't used sedatives or analgesics in past 24h before treatment.
not having allergies to anesthetic drugs.
Intervention groups
adding Dexmedetomidine to Lidocaine or plain Lidocaine in local anesthesia.
Main outcome variables
Boosting the success of the Inferior Alveolar Nerve Block.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150815023620N8
Registration date:2018-07-08, 1397/04/17
Registration timing:retrospective
Last update:2018-07-08, 1397/04/17
Update count:0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Mohammadreza Moshari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
rmoshari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of adding Dexmedetomidine to Lidocaine in success of inferior alveolar nerve block in patients with asymptomatic irreversible pulpitis
Public title
Dexmedetomidine in success of nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a tooth with asymptomatic irreversible pulpitis
ASA Cl I,II
Age (between 18-65 ys )
Exclusion criteria:
Pregnancy
Lactation
Smoking
Addiction
taking psychologic drugs
taking sedatives/analgesics in last 24h before treatment
Having allergies to anesthetics
systemic disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Randomized block method with equal-sized group.
Unit of randomization: Individual.
Tools: Statistical software excel version 10.
Allocation concealment: Coding of samples and sealed envelopes placement.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blinded; The operator and patients are blinded since the operator(endodontist) receives a sealed envelope containing drugs with code break system. Patients are examined while are aware of identity of study and declaration of consent from being involved in study without being informed of the content of drug. The evaluator measures and records the result of Visual Analog Scale test and Electric Pulp Test
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Islamic Azad University of Tehran, Dental Branch
Street address
9th Neyestan aly., Pasdaran st.
City
Tehran
Province
Tehran
Postal code
19486
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,7
Health conditions studied
1
Description of health condition studied
asymptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Inferior Alveolar Nerve blockage
Timepoint
during endodontic treatment
Method of measurement
visual analogue scale
2
Description
feeling of tingling
Timepoint
10min after intervention
Method of measurement
Electric pulp tester
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:Dexmedetomidine 0.5µ\kg (0.4ml) + Lidocaine 1.55%(1.4ml) Dexmedetomidine is manufactured by Hospira. Each patient in Intervention group recieves an Inferior Alveolar Nerve Block injection containing described composition.
Category
Treatment - Drugs
2
Description
Control group: Lidocaine 2% (1.4ml) + Normal saline(0.4ml)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontics Department of Dentistry Faculty of Tehran Azad University
Full name of responsible person
Zahra Vahedi
Street address
9th Neyestan aly., Pasdaran st.
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2256 4570
Email
farva93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Azad University, Dentistry Faculty
Full name of responsible person
Zahra Vahedi
Street address
9th Neyestan aly., Pasdaran st., Tehran.
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2256 4570
Email
farva93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Azad University, Dentistry Faculty
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirabbas Moshari
Position
Endodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neyestan aly., Pasdaran st.
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2281 8161
Fax
Email
amirabbas.moshari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Moshari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
department of anesthesiology, Taleghani hospital, Daneshjou ave. , velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2595
Fax
Email
rmoshari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirabbas Moshari
Position
endodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neyestan aly., Pasdaran st. , Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19486
Phone
+98 21 2256 4570
Fax
Email
amirabbas.moshari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available