The efficacy comparison of Ibuprofen, Gelofen, and
Acetaminophen premedication on the depth of
anesthesia during treatment of mandibular molar teeth
with irreversible pulpitis
The objective of this research was to compare the efficacy of premedication with Ibuprofen, Gelofen, or Acetaminophen on the depth of anesthesia during the treatment of teeth with irreversible pulpitis. This double- blind, randomized controlled clinical trial was done in 60 patients diagnosed with irreversible pulpitis in a mandibular tooth requiring Root Canal Therapy (RCT). Patients indicated their pain scores on a 10-point visual analogue scale (VAS), after which they were randomly divided into 4 groups (n=15). The subjects received identical capsules containing 400 mg Ibuprofen, or 400 mg Gelofen, or 325 mg Acetaminophen, or 500 mg Gloucose powder (placebo), 30 minutes before administration of inferior alveolar nerve block (IANB) with 2% lidocaine containing 1:80000 epinephrine. Lower lip and tongue tip numbness was assessed after 10 minutes, following which the teeth were tested with an electric pulp tester (EPT) and cold spray and their responses (negative or positive) were recorded. Access cavities were then prepared and the intensity of pain was scored based on VAS before the procedure, during access into the dentin, and when the pulp was exposed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010094890N1
Registration date:2012-12-15, 1391/09/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-15, 1391/09/25
Registrant information
Name
ZahraSadat Madani
Name of organization / entity
Endodontics ward, Babol university of Medical Scicences
Country
Iran (Islamic Republic of)
Phone
+98 11 1220 0403
Email address
z.madani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Babol University of Medical Sciences
Expected recruitment start date
2010-05-08, 1389/02/18
Expected recruitment end date
2011-05-08, 1390/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy comparison of Ibuprofen, Gelofen, and
Acetaminophen premedication on the depth of
anesthesia during treatment of mandibular molar teeth
with irreversible pulpitis
Public title
Effect of premedication on the depth of anesthesia during treatment of teeth diagnosed with irreversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with the signs and symptoms of irreversible pulpitis in a mandibular molar tooth. Exclusion criteria: presence of any systemic diseases; consumption of any analgesics for at least 12 hours before enrollment in the study; presence of any contraindication to take Ibuprofen , Gelfen, Acetaminophen or 2% lidocaine with 1:800,00 epinephrine, or injection teqniques; teeth with extended restorations; previous endodontic treatment; advanced periodontal disease and periapical Radiolucency.
Age
From 14 years old to 55 years old
Gender
Both
Phase
2
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
Babol University of Medical sciences
Street address
Ganj Afrooz ave.
City
Babol
Postal code
Approval date
2010-04-12, 1389/01/23
Ethics committee reference number
1664
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
intensity of pain
Timepoint
before endodontic procedure, during access into dentin, when entering the pulp chamber