Investigation of the Effect of topical application of amitriptyline and nortriptyline on irreversible pulpitis pain in teeth with failed pulpal anesthesia after a successful inferior alveolar nerve block
Determining the local effect of amitriptyline and nortriptyline drugs on teeth with irreversible pulpitis in which the successful injection of mandibular block anesthesia did not cause pulpal anesthesia.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized on 45 patients, random number table were used for randomization.
Settings and conduct
This study was done at the Endodontics Department of School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients requiring endodontic treatment of mandibular first molars showing the signs and symptoms of irreversible pulpitis and required treatment. Who had evidence of successful IAN block.
Exclusion criteria: History of hypersensitivity to TCAs, lidocaine or epinephrine, Lack of Systemic diseases,
Pregnancy and nursing mothers,
Patients who took systemic analgesics within 4-6 hours prior to dental visit, Patients with complete anesthesia and no pain.
The age of 10-68 years.
Intervention groups
Intervention group 1: Amitriptyline intervention
Intervention group 2: Nortriptyline intervention
Control group: starch powder as the placebo.
Main outcome variables
The main variable is pulpitis pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230313057710N1
Registration date:2023-04-27, 1402/02/07
Registration timing:retrospective
Last update:2023-04-27, 1402/02/07
Update count:0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Zahra Khosravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 2100
Email address
z.khosravani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-13, 1398/04/22
Expected recruitment end date
2019-12-28, 1398/10/07
Actual recruitment start date
2019-07-13, 1398/04/22
Actual recruitment end date
2019-12-28, 1398/10/07
Trial completion date
2019-12-28, 1398/10/07
Scientific title
Investigation of the Effect of topical application of amitriptyline and nortriptyline on irreversible pulpitis pain in teeth with failed pulpal anesthesia after a successful inferior alveolar nerve block
Public title
Investigation of the Effect of topical application of amitriptyline and nortriptyline on irreversible pulpitis pain in teeth with failed pulpal anesthesia after a successful inferior alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients requiring endodontic treatment of mandibular first molars showing the signs and symptoms of irreversible pulpitis and required treatment.
Who had evidence of successful IAN block.
Age 10-68 years
Exclusion criteria:
History of hypersensitivity to TCAs, lidocaine or epinephrine
Lack of Systemic diseases (In according to self-report)
Pregnancy and nursing mothers
Patients who took systemic analgesics within 4-6 hours prior to dental visit,
Patients with complete anesthesia and no pain.
Age
From 10 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient will allocated a code and the patients assigned to three groups of 15 using a table of random numbers. In this way, intervention group 1 was assigned a two-digit code from 01 to 15, intervention group 2 was assigned a two-digit code from 16 to 30, and the control group was assigned a code from 31 to 45. Then, a number was randomly selected from the table of random numbers by placing a finger on it, and from the beginning of the selected number, the numbers were read in pairs in order. The numbers above 45 were removed, but the numbers between 01 and 45 were placed in one of 3 groups depending on the initial code assigned to each person in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and the dentist (researcher) were blind to the tube contents (double-blind design). Each Eppendorf tube was coded such that the dentist did not aware of its content. A coded Eppendorf tube was assigned to each patient by someone not involved in the study. After measuring the level of pain of patient during access cavity preparation and prior to pulp exposure, one Eppendorf tube randomly was assigned to each patient while the dentist did not aware of type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Ave, Isfahan University of Medical Sciences, Faculty of Dentistry, Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
7346181746
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.204
Health conditions studied
1
Description of health condition studied
Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
[The outcome variable is Irreversible pulpitis.
Timepoint
Pain will measure three times including: prior to the treatment onset, after the injection of anesthetic agent and initiation of access cavity preparation as the patient felt pain for the first time, and also after the application of medication
Intervention group 1: The diagnosis of irreversible pulpitis was confirmed by the heat and cold tests and presence of signs and symptoms of irreversible pulpitis such as severe long-lasting pain response to cold test, and pain during access cavity preparation (prior to pulp exposure). Patients showed signs of successful anesthetic injection 15 minutes after the IAN block injection of 2% lidocaine and 1:80,000 epinephrine (Darupakhsh Company, Tehran, Iran). 10 mg of amitriptyline (daroupakhsh company, Tehran, Iran) was prescribed. The colored coating of the tablets was removed and each tablet was powdered and mixed with 2 cc saline in an Eppendorf tube until a homogenous solution was obtained. The tubes were coded such that the dentist was blinded to the contents of each tube. The tube content was applied on exposed dentin by a microbrush, and a cotton pellet was placed over it, followed by a cotton roll and then the patient was requested to bite on it for 3 minutes. After this time period, the dentist continued the process of access cavity preparation and the pain score was measured again. Pain was measured three times prior to the treatment onset, after the injection of anesthetic agent and initiation of access cavity preparation as the patient felt pain for the first time, and also after the application of medication using the McGill visual analog scale (VAS) and Wong-Baker Faces Pain Rating Scale (PRS)
Category
Treatment - Drugs
2
Description
Intervention group 2: 10 mg of Nortriptyline ( Sobhan darou company, Tehran, Iran) was prescribed. The method of prescribing, intervention and data measurement were the same as the intervention 1.
Category
Treatment - Drugs
3
Description
Control group: Placebo including 10 mg starch was prescribed. The method of prescribing, intervention and data measurement were the same as the first intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontics Department of Schoo Dentistry
Full name of responsible person
Hossein Baharian
Street address
Hezarjarib Ave, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
z.khosravani@dnt.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Armita Vali Sichani
Street address
Hezarjarib, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
a.valisichani@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Khosravani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezarjarib, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
z.khosravani@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Armita Vali Sichani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezarjarib Avenu, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfehan
Province
Isfehan
Postal code
0098 3136680048
Phone
+98 81 7467 3461
Email
a.valisichani@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Khosravani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezarjarib Avenu, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
z.khosravani@dnt.mui.ac.ir
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