Protocol summary

Summary
Periapical lesions are inflammatory diseases that extend following bacterial canal infection. In this study, we are looking for the role of prophylactic ibuprofen and N-acetylcysteine on the levels of TNF- α and IL-6 in chronic periapical lesions. Periapical radiographs are taken using bisecting technique and patients with radiolucencies less than 1 cm are randomly assigned to one of following four groups to receive ibuprofen 400 mg, NAC600 mg , Ibuprofen 200+NAC600 mg, or placebo (starch). Medications are made using 500 mg gelatinous capsules. The pain severity is recorded using visual analog scale (VAS). Each patient receives 2 similar capsules 2 hours and 30 minutes prior sampling. Then, the patient is anesthetized, the tooth is isolated and the access cavity is provided. Canal preparation is done up to size #40 file for single rooted teeth and size #30 file for multi-rooted teeth. Irrigation with normal saline is done and the canal is dried with paper points. Two paper points with size 30 are inserted in the canal and each kept in place for 30 seconds for exudates sampling. For teeth with active drainage, the points are kept with shorter time. If blood is observed, the sample is excluded, and if the point is dry, a fine file (size 8 or 10) passes the foramen and lets the exudates come into the canal. The wet length of the paper point is recorded and the volume of the fluid is calculated using Shimauchi standard curve in μl. the point is inserted in a microtube containing phosphate buffered saline (PBS) with 0.05% twin 20. They are vortexed for 1 minute, and centrifuged, and the supernatant is isolated and kept in-70̊ C. VAS is repeated 4, 8, 12 and 24 hours later. Samples are analyzed using ELISA and cytokine levels are compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008114547N1
Registration date: 2010-03-20, 1388/12/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-20, 1388/12/29
Registrant information
Name
Samir Zahedpasha
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 4032
Email address
samirzahedpasha@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of prophylactic ibuprofen and N-acetylcysteine on the levels of TNF- α and IL-6 in chronic periapical lesions
Public title
The effect of ibuprofen on chronic periapical lesions
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: periapical lesions less than 1 cm, accessibility to whole canal length, signing written informed consent Exclusion criteria: Presence of systemic disorder, pregnancy, breast feeding, menopause, drug intake during last 48 hours, smoking or drug abuse, alcohol intake during the last 3 days, any allergy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz street, Babol
City
Babol
Postal code
4717641367
Approval date
2010-06-22, 1389/04/01
Ethics committee reference number
811

Health conditions studied

1

Description of health condition studied
chronic apical periodontitis
ICD-10 code
KO4.5
ICD-10 code description

Primary outcomes

1

Description
IL-6
Timepoint
2 hours after intervention
Method of measurement
enzyme-linked immunosorbent assay

2

Description
TNF-ALPHA
Timepoint
2 hours after intervention
Method of measurement
enzyme-linked immunosorbent assay

Secondary outcomes

1

Description
pain
Timepoint
4, 8, 12 and 24 hours after intervention
Method of measurement
visual analog scale

Intervention groups

1

Description
Ibuprofen 400 mg in a 500 mg gelatinous capsule, 2 hours and 30 minutes prior to sampling
Category
Treatment - Drugs

2

Description
NAC600 mg mg in a 500 mg gelatinous capsule, 2 hours and 30 minutes prior to sampling
Category
Treatment - Drugs

3

Description
Ibuprofen 200 mg + NAC600 mg in a 500 mg gelatinous capsule, 2 hours and 30 minutes prior to sampling
Category
Treatment - Drugs

4

Description
Placebo (starch) in a 500 mg gelatinous capsule, 2 hours and 30 minutes prior to sampling
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of dentistry, Babol University of Medical Sciences
Full name of responsible person
Maryam Ehsani, Samir Zahedpasha
Street address
Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Babol University of Medical Sciences
Street address
Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Facuilty of dentistry, Babol University of Medical Sciences,
Full name of responsible person
Samir Zahedpasha
Position
Resident
Other areas of specialty/work
Street address
Babol
City
Babol
Postal code
Phone
+98 11 1222 4032
Fax
Email
samirzahedpasha@mubabol.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samir Zahedpasha
Position
Resident
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1222 4032
Fax
Email
samirzahedpasha@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Samir Zahedpasha
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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