Evaluation of the effect of common analgesics on dental pulp vitality tests
Design
A randomized, blinded, controlled clinical trial with a parallel group design of 41 patients with symptomatic irreversible pulpitis
Settings and conduct
This study was carried out on patients with diagnosis of symptomatic irreversible pulpitis in dentistry School of Tehran University of Medical Sciences. Cold test and electric pulp test were performed on the tooth with irreversible pulpitis and a sound tooth.Then, either 400 mg Gelofen, 500 mg acetaminophen or placebo was prescribed for the patients. The medications were packed in quit similar packing in order to unawareness(making blind) of the examiner.Vitality tests were then performed on the same teeth at 20, 40 and 60 min after medication intake. Sensitivity to cold test was quantified using a visual analog scale (VAS).
Participants/Inclusion and exclusion criteria
The inclusion criteria : age between 18 to 65 years, systemic health, emergency admission due to symptomatic irreversible pulpitis with moderate to severe pain and prolonged pain response to cold test, and no history of analgesic intake or use of nervous system depressants during the past 6 h.
The exclusion criteria : contraindications for taking acetaminophen and/or Gelofen, tooth did not response to cold test, and those who had dental pain originated from periapical tissues.
Intervention groups
Intervention Group 1: was prescribed 400 mg Gelofen
Intervention Group 2: was prescribed 500 mg acetaminophen
Control Group : was prescribed placebo
Main outcome variables
- The pulp response to cold test in teeth with symptomatic irreversible pulpitis and sound teeth in Visual Analogue Scale
- The pulp response of teeth with symptomatic irreversible pulpitis and sound teeth to Electric Pulp Tester
Both : at the onset of study and at 20, 40 and 60 minutes after medication intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200322046836N1
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Fatemeh Dibaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1149
Email address
f-dibaji@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-10-02, 1398/07/10
Scientific title
ُStudy of the effect of commonly used analgesics on response of teeth with symptomatic, irreversible pulpitis to pulp vitality tests
Public title
Effect of commonly used analgesics on response of teeth with symptomatic, irreversible pulpitis to pulp vitality tests
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to 65 years, systemic health, emergency admission due to symptomatic irreversible pulpitis with moderate to severe pain and prolonged pain response to cold test, and no history of analgesic intake or use of nervous system depressants during the past 6 h.
Exclusion criteria:
contraindication for taking acetaminophen and/or Gelofen, patients whose tooth did not response to cold test, and those who had dental pain originated from periapical tissues.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
54
Actual sample size reached:
41
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
medications (both real tablets and placebo) were in quite similar packing , so that the examiner was unaware of the type of the medicine in the each packing.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor,Central building of Tehran University of Medical Sciences, Qods str., Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.4724
Health conditions studied
1
Description of health condition studied
Symptomatic irreversible pulpitis
ICD-10 code
K04. 02
ICD-10 code description
Irreversible pulpitis
Primary outcomes
1
Description
the pulp response to cold test in teeth with symptomatic irreversible pulpitis and sound teeth in Visual Analogue Scale
Timepoint
at the onset of study and at 20, 40 and 60 minutes after medication intake
Method of measurement
The values are based on Visual Analogue Scale and in millimeters
2
Description
the pulp response of teeth with symptomatic irreversible pulpitis and sound teeth to EPT
Timepoint
at the onset of study and at 20, 40 and 60 minutes after medication intake
Method of measurement
The degree displayed by the electric pulp tester when the patients felt pain, burning sensation or heat.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a single dosage of 400 mg Gelofen (Dana,Tehran,Iran) was prescribed and then dental vitality tests were carried out at 20, 40 and 60 minute later.
Category
Diagnosis
2
Description
Intervention group: 500 mg acetaminophen was prescribed(Kharazmi, Tehran, Iran) and then dental vitality tests were carried out at 20, 40 and 60 minute later.
Category
Diagnosis
3
Description
Control group: a single dosage of placebo tablet was prescribed and then dental vitality tests were carried out at 20, 40 and 60 minute later.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Sooratgar-Aidin
Street address
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St. Zam Zam St. Navab Highway, Tehran, Iran, P.O. code: 1894787545
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1149
Fax
+98 21 5585 1141
Email
a-sooratgar@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical science, International campus
Full name of responsible person
Reza Yazdani
Street address
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St. Zam Zam St. Navab Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1149
Email
f-dibaji@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical science, International campus
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Dibaji
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St. Zam Zam St. Navab Highway, Tehran, Iran, P.O. code: 1894787545
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
0982155851149
Email
f-dibaji@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aidin Sooratgar
Position
Asisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St. Zam Zam St. Navab Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
+98 21 5585 1149
Fax
Email
a-sooratgar@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Dibaji
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, International Campus, School of Dentistry Mahan St. Zam Zam St. Navab Highway, Tehran, Iran, P.O. code: 1894787545
City
Tehran
Province
Tehran
Postal code
1894787545
Phone
0982155851149
Email
f-dibaji@tums.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