The Effect of Oral Premedication with Novafen, Naproxen, and Ibuprofen on the Success of the Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis
The effect of oral premedication with Novafen, Naproxen, and Ibuprofen on the success of inferior alveolar nerve block for teeth with acute irreversible pulpitis
Design
Clinical trial with control group, with parallel groups, triple-blind, randomized, phase 1 on 125 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:
1. acute pulpal pain an a mandibular molar
2. signs and symptoms indicating pulp vitality
3. Age 20 to 55 years
4. No medication 8 hours before treatment
5. No severe apical periodontitis
6. The ability to sense pain factors
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 one tablet of 250 mg Naproxen (ParsPharmaceutical Co., Tehran, Iran) one hour before treatment
Group 4: premedication with placebo one hour before treatment
Group 5: no premedication
Main outcome variables
The level of anaesthesia
General information
Reason for update
Acronym
پیش درمانی
IRCT registration information
IRCT registration number:IRCT20200504047302N2
Registration date:2020-06-10, 1399/03/21
Registration timing:registered_while_recruiting
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
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
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Premedication with Novafen, Naproxen, and Ibuprofen on the Success of the Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis
Public title
The Effect of Oral Premedication with Novafen, Naproxen, and Ibuprofen on the Success of the Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 55 years
acute irreversible pulpitis
mandibular molar
The ability of understanding the pain factors
No medication in the past 8 hours
Exclusion criteria:
Severe apical periodontitis
Sign or symptoms indicating pulp necrosis
Systemic disease
Pregnant or milking patient
Allergic reactions to drugs
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
125
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (computer creates random numbers between 0 and 5; 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, numbers between 3 and 4 in group 4, and numbers between 4 and 5 in group 5 Placed)
Blinding (investigator's opinion)
Triple blinded
Blinding description
Preparation of capsules by a person
allocation to patient by another person
treatment by another 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
Mahhsad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
920276
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
A Randomized Clinical Trial Comparing the Effect of Oral Premedication with Novafen, Naproxen, and Ibuprofen on the Success of the Inferior Alveolar Nerve Block for Teeth with Symptomatic Irreversible Pulpitis
Timepoint
1 HOUR AFTER DRUG CONSUMPTION
Method of measurement
Heft Parker method of pain measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: - Group 1: premedication with Ibuprofen 400 mg (Neda pharmaceutical company), 1 hour before treatment
Category
Other
2
Description
Intervention group: premedication with Novafen (Alhavi pharmaceutical company), 1 hour before treatment
Category
Other
3
Description
Intervention group: premedication with Naproxen 250 mg (Pars pharmaceutical company, 1 hour before treatment
Category
Other
4
Description
Control group: premedication with placebo, 1 hour before treatment
Category
Placebo
5
Description
Control group: no premedication
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry
Full name of responsible person
Hamid Jafarzadeh
Street address
Vakilabad Blvd
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 Tafaghodi
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
Email
hamid_j365@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not 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 centers
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