Compariosn of the combination of premedication with ibuprofen plus inferior alveolar block plus buccal infiltration with inferior alveolar block plus buccal infiltration on anesthesia success of posterior mandibular teeth with irreversible pulpitis: A three blinded randomized clinical trial
Achieving pulp anesthesia with irreversible pulpitis is difficult. This study evaluate whether nonsteroidal anti-inflammatory drugs assist local anesthesia.
In a randomized double-blinded clinical trial, 100 patients (50 per group) with irreversible pulpitis will give placebo, 600 mg ibuprofen, 1 hour before local anesthesia. Each patient recorded their pain score on a visual analog scale before taking the medication, 15 minutes after anesthesia in response to a cold test, during access cavity preparation and during root canal instrumentation. No or mild pain at any stage was considered a success. Data will analyze by the chi-square test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611242016N7
Registration date:2016-12-20, 1395/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-20, 1395/09/30
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-11-26, 1395/09/06
Expected recruitment end date
2017-01-25, 1395/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compariosn of the combination of premedication with ibuprofen plus inferior alveolar block plus buccal infiltration with inferior alveolar block plus buccal infiltration on anesthesia success of posterior mandibular teeth with irreversible pulpitis: A three blinded randomized clinical trial
Public title
Effect of different factors on the in-operative relief pain in root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 or more than 18 years, no contraindications to taking either Ibuprofen (history of any allergic reaction to aspirin, NSAIDS, or Lidocaine with Epinephrine, nasal polyp, history of peptic ulcers or GI bleeding, pregnancy and lactation, renal or hepatic disease), no history of GI disorders or ulcer, having no serious systemic disease.
Exclusion criteria: no response to cold test, having sensitivity to percussion and palpation, having radiographic changes such as PDL widening, lack of vital pulp in coronal pulp chamber access cavity preparation, teeth with evidence of crack in their crown, having advanced periodontal disease, taking narcotic drugs or analgesic drugs in recent 24 hours before treatment.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Sciences
Street address
Vice-chancellor for Research, Building of kerman University of Medical Sciences, Tahmaseb-abad cross, Jahad Street
City
kerman
Postal code
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
IR.KMU.REC.1395.13
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Response to cold test
Timepoint
Before taking drug, 1 hour after taking drug before anesthetic injection, after local anesthetic injecyion
Method of measurement
Cold spray
Secondary outcomes
1
Description
In-operative pain
Timepoint
In access cavity preparation and during treatment
Method of measurement
Using Visual Analogue Scale (VAS)
Intervention groups
1
Description
Ibuprofen: 1 capsule of 600 mg, 1 hour before the local anesthetic injection
Category
Treatment - Drugs
2
Description
placebo: 1 capsule contain 500 mg lactos mono hydrate, 1 hour before the local anesthetic injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic Department, Kerman Dental School
Full name of responsible person
Dr. Masoud Parirokh
Street address
School of Dentistry, Shafa street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology
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
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Abbas Pardakhti
Position
Dean of the center
Other areas of specialty/work
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building
City
kerman
Postal code
Phone
+98 34 3226 3815
Fax
Email
kmu_research@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endodontics Department, School of Dentistry
Full name of responsible person
DR. Masoud Parirokh
Position
Full Professor
Other areas of specialty/work
Street address
Endodontic Department, School of Dentistry, Shafa street
City
Kerman
Postal code
Phone
+98 34 3245 7931
Fax
Email
masoudparirokh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman School of Dentistry
Full name of responsible person
Nima Hatami
Position
Postgraduate student
Other areas of specialty/work
Street address
Endodontic Department, School of Dentistry, Shafa street
City
Kerman
Postal code
Phone
00
Fax
Email
n.htami66@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)