this study aimed to determine the effect of Nabumetone (500&750mg)premedication compared with ibuprofen 400 mg on pain after root canal treatment in patients with symptomatic irreversible pulpitis referring to Endodontics Department of Dental Branch, Islamic Azad University, Tehran, Iran during the year of 1396-97.
Design
Pragmatic, community based, parallel group, double blind, randomized controlled trial
Settings and conduct
This double-blind(a similar shape of medicines was prepared in intervention & placebo groups & evaluator & prescriber are different.) , randomized, and placebo controlled clinical trial was conducted on 88 eligible patients with moderate to severe pain who needed root canal treatment for molar teeth with the diagnosis of irreversible pulpitis.The dental pain level more than 54 according to HP-VAS is considered sympathetic . Patients are divided into 4 groups according to the randomized table: Ibuprofen (400 mg )is administered to the first case group, Nabumetone ( 750 mg ) for the second group , Nabumetone( 500 mg) for third group and oral placebo for control group . The patient, the person evaluating and controlling, are blind to the allocation. After about 30 minutes,anesthetizing is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1-symptomatic Irreversible pulpitis
2- Healthy participants without systemic disease
3-First & second molar of maxilla & mandible
Exclusion criteria :
1- Systemic disease
2- Pregnancy and lactation
3- Taking analgesics in the last 12 hours
4- Allergic drugs
5- Periodontitis and periodontal ligament widening more than 1 mm
6- History of root canal therapy
Intervention groups
Intervention group 1: Nabumetone 750 mg;
Intervention group 2: Nabumetone 500 mg;
Intervention group 3: Ibuprofen 400 mg;
Control group: Placebo (vitamin B)
Tehran Medical Science Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8875 9644
Email address
p_mehrvarzfar@dentaliau.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-04-21, 2018/02/01
Expected recruitment end date
2639-10-23, 2018/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of prophylactic prescription of Nabumetone and Ibuprofen on postoperative pain in symptomatic irreversible pulpitis
Public title
Effect of Nabumetone on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
symptpmatic irreversible pulpitis
healthy participants( ASAI &ASAII)
first & second molar of maxilla & mandible
Exclusion criteria:
systemic disease
pregnancy and lactation
taking analgesics in the last 12 hours
allergic drugs
periodontitis & PDLwidening more than 1 mm
History of RCT
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind study:
1.researcher who prescribes drugs is blinded to the case & placebo medications due to all medications are encapsulated in identical size & shape capsules in pharmaceutical company.
2.patient is also blinded due to who does not know about the containing capsules.
3.outcome assessor is the main researcher who does not know about the prescribed medications.
4. statistician is absolutely blinded to prescription and assessment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics Committee of Tehran Medical Science Branch, Islamic Azad University
Street address
No.4, Neyestan 10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19858175
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,4
Health conditions studied
1
Description of health condition studied
post operative endodontic pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain severity
Timepoint
measurement of pain severity before Intervention & 6,12,24,48 hours after finish the Intervention
Method of measurement
heft parker visual analog scale (0_170 mm)
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group1":Nabumetone 750 mg, non steroidal anti-inflammatory drugs prescribe 30 minutes before intervention.
Category
Treatment - Drugs
2
Description
"Intervention group": Nabumetone 500 mg non steroidal anti-inflammatory drugs prescribe 30 minutes before intervention.
Category
Treatment - Drugs
3
Description
"Intervention group": Ibuprofen 400 mg non steroidal anti-inflammatory drugs prescribe 30 minutes before intervention.
Category
Treatment - Drugs
4
Description
"Control group": Placebo , prescribe 30 minutes before intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Dental Branch , Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4570
Email
p_mervarzfar@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Dental Branch, Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
a_azizi@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Dental Branch, Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
p_mehrvarzfar@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Peymam Mehrvarzfar
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
P_mehrvarzfar@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Peyman Mehrvarzfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.4, Neyestan10 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
P_mehrvarzfar@dentaliau.ac.ir
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
There is no further 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
only some parts of data including age,gender & post operative pain intensity would be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Dental academic groups would receive the data provided that they contact with researching authorities.
What processes are involved for a request to access data/document
Authorized letter from scientific organization should be sent to Tehran dental branch Islamic Azad University .Next following approval by competent authorities the data would be released during a period of 6 month.