Clinical trial to comparison of bupivacaine(local) and mefnamic acid on mean pain score reported during the first 24 hours after surgical extraction of third molar, in patients with similar bilateral impacted lower third molar.
Objectives: Determination of the effect of injection of bupivacaine by patient into the tooth socket on pain management after surgical extraction of impacted lower third molar.
Design: randomized, double blind, cross-over, placebo control, with in groups, single center, phase 2-3 trial.
Participants including major eligibility criteria:
major inclusion criteria: Patients with similar bilateral impacted lower third molar.
major exclusion criteria: The length of two surgery of one patient have more than 10 min difference.
Target sample size: 48.
Setting and conduct: After each surgery of one patient that is performed with a time span of at least a week, he randomly takes bupivacaine+ placebo of mefnamic acid or mefnamic acid+ normal saline ( placebo of bupivacaine).
Intervention: After each surgery a catheter fix to second molar that patient can inject bupivacaine or normal saline every 2 hours in to the socket of impacted tooth through that. and also they should eat mefnamic acid or placebo of mefnamic acid every 8 hours.
Time of intervention: During 24 hours following surgery(eating mefnamic or placebo of mefnamic) and 12 hours after surgery(injection of bupivacaine or normal saline).
Main outcome measures: mean pain score reported by patients during the first 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204199515N1
Registration date:2013-01-15, 1391/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-15, 1391/10/26
Registrant information
Name
Ideh Talimkhani
Name of organization / entity
Hamadan faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 2144
Email address
i.talimkhani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-04-19, 1391/01/31
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to comparison of bupivacaine(local) and mefnamic acid on mean pain score reported during the first 24 hours after surgical extraction of third molar, in patients with similar bilateral impacted lower third molar.
Public title
Evaluation of the effect of injection of bupivacaine by patient into the tooth socket on pain management after surgical extraction of impacted lower third molar
Purpose
Other
Inclusion/Exclusion criteria
Major inclusion criteria: The patients with similar bilateral impacted lower third molar; Patients that have no contraindications for oral surgery; Patients that are able to understand the method of our study.
Major exclusion criteria: The length of two surgery of one patient have more than 10 min difference; Not using of drug according to the method that is trained.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2012-01-05, 1390/10/15
Ethics committee reference number
3592/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
impacted teeth
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth
Primary outcomes
1
Description
Post surgical pain
Timepoint
24 hours following surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Placebo of mefnamic acid 250 mg, every 8 hours during 24 hours following surgery.
Category
Placebo
2
Description
Intervention group: Injection of 0.3 cc bupivacaine 0.5% in to the tooth socket, every 2 hours during 12 hours following surgery.
Category
Treatment - Drugs
3
Description
Control group: Injection of 0.3cc normal saline in to the tooth socket, every 2 hours during 12 hours following surgery.
Category
Placebo
4
Description
Control group: Mefnamic acid 250 mg, every 8 hours during 24 hours following surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan faculty of dentistry
Full name of responsible person
Ideh Talimkhani
Street address
Faculty of dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Vice chancellor for research, Hamedan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
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, Hamedan University of Medical Sciences