The objective of this research was to compare the efficacy of premedication with Ibuprofen and Meloxicam on the depth of anesthesia in lower molar teeth with irreversible pulpitis. This double- blind, randomized controlled clinical trial was carried out on 92 patients referred to endodontic department o Shahid Beheshti Dental School. All the patients presented symptoms of irreversible pulpitis in first mandibular tooth and required Root Canal Therapy. Patients were randomly divided into 4 groups of 23 patients.The first group received no premedication, second group received 7.5 mg meloxicam, third group received 600 mg ibuprofen and the fourth group received placebo one hour before administration of inferior alveolar nerve block (IANB) with 2% lidocaine containing 1:80000 epinephrine. Before taking the medication, electrical pulp testing (EPT) and the Heft-Parker visual analog scale (VAS) were used to evaluate the sensitivity and pain at the baseline. After 15 minutes lower lip and tongue tip numbness was assessed, and then EPT was used again to evaluate the tooth sensitivity. The pain during access preparation was also recorded using the Heft-parker VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071423207N1
Registration date:2015-10-22, 1394/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Amir Movahhedian
Name of organization / entity
Shahid Beheshti Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5351
Email address
amirmovahedian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Dentsal School, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Preoperative Ibuprofen and Meloxicam on the Success rate of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis
Public title
efficacy of premedication on success rate of anesthesia in lower jaw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with the signs and symptoms of irreversible pulpitis in mandibular first molar tooth.
Exclusion criteria: presence of any systemic diseases; pregnancy or breast-feeding; taking any kind of medications within a period of 8 h prior to the treatment that could interfere with the medications used in this study; teeth with extensive coronal restorations; casting restorations; previous root canal therapies; severe periodontal diseases and peri apical radiolucencies; and contraindications to the drugs used in this study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Chamran highway Evin Daneshjoo Blvd
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
357
Health conditions studied
1
Description of health condition studied
Irriversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Irriversible pulpitis
Primary outcomes
1
Description
tooth sensitivity
Timepoint
before intervention and one hour after intervention
Method of measurement
using EPT device
2
Description
pain level
Timepoint
before intervention and one hour after intervention
Method of measurement
using Heft Parker visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
600 mg ibuprofen one hour before anesthesia
Category
Treatment - Drugs
2
Description
7.5 mg meloxicam one hour before anesthesia
Category
Treatment - Drugs
3
Description
placebo filled with starch powder
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Dental School
Full name of responsible person
Dr Omid Dianat
Street address
Daneshjoo Blvd, Chamran Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy, Dentsal School, Shahid Beheshti University of Medical Schiences
Full name of responsible person
Dr arash Khojaste
Street address
Daneshjoo Blvd, Evin, Chamran Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, Dentsal School, Shahid Beheshti University of Medical Schiences
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
Shahid Beheshti Dental School
Full name of responsible person
Dr Omid Dianat
Position
Associate professor of Shahid Beheshti University of Medical Sciences
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5351
Fax
Email
omiddianat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr Omid Dianat
Position
Associate Professor of Shahid Beheshti University of Medical Sciences
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5351
Fax
Email
omiddianat@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr Omid Dianat
Position
Associate Professor of Shahid Beheshti Uneversity of Medical Schiences
Other areas of specialty/work
Street address
Daneshjoo Blvd, Evin, Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5351
Fax
Email
omiddianat@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)