Evaluation the effect of intraligamentry injection of the Lornoxicam on the post-operative endodontic pain in tooth with symptomatic irreversible pulpitis (Clinical Trial Study)
Purpose: To determine the effect of intraligamentry injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis on volunteer patients who are referred to the Endodontic department of Dental University of Islamic Azad University of Tehran in 2011-2012. Design of study: Placebo – Controlled Double Blind Clinical Trial Study. Inclusion criteria: Patients with first or second mandibular molars who need endodontic treatment and with clinical evidence of irreversible Pulpits with moderate to severe pain. Exclusion criteria: Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs; People who have a history of acute peptic ulcer, during the past 12 months; People who have bleeding problems or have been taking anticoagulant drugs over the past month; Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs. Forty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in two groups which both will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the control group wil be injected with 0.4 mL of 2% Lidocain with EP 1/180000 (as placebo). Then the patients’ pain will be evaluated with visual Analogue Scale analysis (VAS) 0-9 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108017191N1
Registration date:2011-10-09, 1390/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-09, 1390/07/17
Registrant information
Name
Mandana Abedi Tari
Name of organization / entity
Dental School of Tehran Azad University
Country
Iran (Islamic Republic of)
Phone
+98 912 397 7265
Email address
peymanm@dentiau.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of intraligamentry injection of the Lornoxicam on the post-operative endodontic pain in tooth with symptomatic irreversible pulpitis (Clinical Trial Study)
Public title
Evaluation the effect of the Lornoxicam on the post-operative endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy (ASA I, II); Patients with first or second mandibular molars who need endodontic treatment; Vital tooth without a history of past endodontic treatment; Patients with clinical evidence of irreversible Pulpits with moderate to severe pain; Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images; Patients in the age group of 18-65 years old. Exclusion criteria: Pregnant or nursing; necrotic tooth; Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs; People who have a history of acute peptic ulcer, during the past 12 months; People who have bleeding problems or have been taking anticoagulant drugs over the past month; Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 committe of Dental School of Tehran Azad University
Street address
No. 4, 10th alley, Pasdaran Ave
City
Tehran
Postal code
1946853314
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
440
Health conditions studied
1
Description of health condition studied
Post operative endodontic pain
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
post oprative endodontic pain
Timepoint
6-12-24-48 hours after treatment
Method of measurement
Visual Analogue Scale (VAS 0-9mm)
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group: After inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam(1.6 mg)
Category
Treatment - Drugs
2
Description
Control group: wil be injected with 0.4 mL of 2% Lidocain with EP 1/180000
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Tehran Azad University
Full name of responsible person
Dr.Peyman Mehrvarzfar
Street address
No. 4, 10th alley, Pasdaran Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
10th neyestan, Pasdran Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Azad University
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
Endodontic department, Dental School of Tehran Azad University