The aim of this study was to evaluate the effect of pretreatment with naproxen sodium on the success of inferior alveolar nerve block for teeth with symptomatic irreversible pulpitis. 60 patients with symptomatic teeth with irreversible pulpitis were randomly assigned to double-blind and placebo controlled clinical study will be selected . the patients will include the study if had not taken any analgesics for at least 12 hours before, had first or second molar of mandible with irreversible pulpitis and normal periapical radiography appearance. Patients will exclude in below conditions: subjects under 18 years of ages, allergies to take Naproxen sodium, allergic reaction to local anesthesia, pregnant women, history of significant medical condition. The patient will receive identical capsules of 550 mg of naproxen sodium or placebo 1 hour before the injection of conventional inferior alveolar nerve block. The Pain on the basis of visual analogue scale will record before treatment and during access cavity preparation and instrumentations. All the patients will control fore 48 after procedure to assess the side effects or flare-ups will associate with the endodontics treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101615041N1
Registration date:2014-10-19, 1393/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Somaye Ghamari
Name of organization / entity
Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 2522 3381
Email address
ghamari.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz jundishapur university of medical science
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Premedication With Naproxen Sodium On success Rate Of inferior alveolar nerve block injection in teeth With irreversible Pulpitis
Public title
decrees pain patient during root canal therapy with consume of analgesic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:the patient included study had not taken any analgesics for at least 12 hours before; have first or second molar of mandible with irreversible pulpitis and normal periapical radiography appearance.
Exclusive criteria:patients under 18 years; patients with allergic to naproxen sodium; patients with a history of sensitivity to local anesthetics; pregnant women; a history of significant medical problems; the people who would not have consent to participate in this research project; aspirin;oral anticoagulant medications or plicamycin taken by the patient; history of angioedema; gastrointestinal disease; peptic ulcer; renal or cardiovascular disease; if the tooth has a vital pulp during cavity preparation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapur University Of Medical Sciences
Street address
Ahwaz/university town
City
Ahwaz
Postal code
61357-15794
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
ajums.REC.1393.175
Health conditions studied
1
Description of health condition studied
Painful irreversible pulpitis
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissue
Primary outcomes
1
Description
Pain score
Timepoint
Befor treatment, During treatment
Method of measurement
VAS (visual analog scale)
Secondary outcomes
1
Description
Any side effects from taking the drug
Timepoint
48 hours after treatment
Method of measurement
Patient chief complaint
Intervention groups
1
Description
control group: placebo capsules in the control group, one hour before treatment, orally, containing starch and a small amount of lactose powder
Category
Placebo
2
Description
Intervention group: Naproxen sodium capsule,550mg,Single dose, orally, one hour before to treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty Of Dentistry, Jundishapur University Of Medical Sciences
Full name of responsible person
Dr Mohammad Yazdizadeh
Street address
Ahwaz, Faculty Of Dentistry
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapur university of Medical Science
Full name of responsible person
Dr Nader Saki
Street address
University town, Jundishapur University Of Medical Science
City
Ahwaz
Grant name
Grant code / Reference number
U.93089
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur university of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jundishapur University Of Medical Science
Full name of responsible person
Dr Mohammad Yazdizadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Ahwaz/University town
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 1336 7543
Fax
+98 33 35200
Email
research@ajums.ac.ir/m2_yazdi@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University Of Medical Science
Full name of responsible person
Dr Mohammad Yazdizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahwaz/University town/Jundishapur University Of Medical Science
City
Ahwaz
Postal code
Phone
+98 61 1336 7543
Fax
Email
research@ajums.ac.ir/m2_yazdi@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University Of Medical Science
Full name of responsible person
Somaye Ghamari
Position
Professional Assistance
Other areas of specialty/work
Street address
Ahwaz/University Town
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 1336 7543
Fax
Email
research@ajums.ac.ir/somaye_ghamari@yahoo.com
Web page address
www.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)