The Effect of Oral Premedication with Novafen and Ibuprofen on the Response of the Patients with Acute Irreversible Pulpitis to the Cold, Heat, Electric, and Pulse Oximetry Tests
The Effect of Oral Premedication with Novafen and Ibuprofen on the Response of the Patients with Acute Irreversible Pulpitis to the Cold, Heat, Electric, and Pulse Oximetry Tests
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 1 on 84 patients. The rand function of the Excel software is used for randomization.
Settings and conduct
Mashhad Faculty of Dentistry
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 55 years
Acute irreversible pulpitis (spontaneous pain or severe and prolonged pain with cold or heat)
Do not take the medicine for at least 8 hours before work
Severe apical periodontitis
Ability to understand pain criteria
Low-rooted single-root permeable and single-channel without extensive decay or extensive repair
Apox evolved
Lack of cover or very extensive repairs
Absence of clinical signs of necrosis
Lack of systemic disease
Exclusion criteria:
The patient has an allergy to one of the drugs being tested
A pregnant or lactating patient
History of significant medical problems
History of active gastric ulcer in the last 12 months
History of bleeding problems or anticoagulants last month
Pain over one tooth
Take the medicine 8 hours before work
Severe apical periodontitis
Absence of acute irreversible pulpitis
Intervention groups
Group 1: premedication with one tablet of 400 mg Ibuprofen (Neda Pharmaceutical Co., Tehran, Iran) one hour before treatment
Group 2: premedication with one tablet of Novafen (Alhavi Pharmaceutical Co., Tehran, Iran) one hour before treatment
Group 3: premedication with placebo one hour before treatment
Group 4: no premedication
Main outcome variables
cold test result; heat test result; electrical test result; pulse oximetry test result
General information
Reason for update
Acronym
پیش درمانی
IRCT registration information
IRCT registration number:IRCT20200504047302N1
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Hamid Jafarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
hamid_j365@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-10, 1399/02/21
Expected recruitment end date
2020-06-10, 1399/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Premedication with Novafen and Ibuprofen on the Response of the Patients with Acute Irreversible Pulpitis to the Cold, Heat, Electric, and Pulse Oximetry Tests
Public title
The Effect of Oral Premedication with Novafen and Ibuprofen on the Response of the Patients with Acute Irreversible Pulpitis to the Cold, Heat, Electric, and Pulse Oximetry Tests
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 55 years
acute irreversible pulpitis
single root/canal mandibular premolar
The ability of understanding the pain factors
Mature apex
Exclusion criteria:
Drug consumption in past 8 hours
Severe apical periodontitis
Clinical sign of necrosis
Systemic disease
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (computer creates random numbers between 0 and 4; numbers between zero and one in the first group, numbers between 1 and 2 in group 2, numbers between 2 and 3 in group 3 and numbers between 3 and 4 in group 4 Placed)
Blinding (investigator's opinion)
Double blinded
Blinding description
Preparation of capsules by a 3rd person (neither the researcher knows what capsule is giving to the patient, nor the patient knows what capsule is taking)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.mums.sd.REC.1394.19
Health conditions studied
1
Description of health condition studied
Pulp disease
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pre-treatment effect on cold test result; pre-treatment effect on heat test; pre-treatment effect on electrical test result; pre-treatment effect on pulse oximetry test result
Timepoint
1 HOUR AFTER DRUG CONSUMPTION
Method of measurement
test result as positive or negative
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Use a 400 mg ibuprofen (Neda, Tehran, Iran) one hour before treatment
Category
Treatment - Drugs
2
Description
Intervention group: Take one novafen (Alhavi, Isfahan, Iran) one hour before treatment
Category
Treatment - Drugs
3
Description
Control group: premedication with placebo one hour before treatment
Category
Placebo
4
Description
Control group: Nopretreatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry
Full name of responsible person
Hamid Jafarzadeh
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9501
Email
hamid_j365@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghghodi
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Jafarzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
hamid_j365@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Jafarzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
hamid_j365@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Jafarzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
hamid_j365@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after removing personal data of participants
When the data will become available and for how long
Open from 2020
To whom data/document is available
Researchers in academic cnters
Under which criteria data/document could be used
Because information lacks individual information, there are no restrictions
From where data/document is obtainable
email to hamid_j365@yahoo.com
What processes are involved for a request to access data/document