The aim of this study is evaluation of the effect of premedication with Iboprofen and Dexamethasone on the success rate of inferior alveolar nerve block. The patients are over eighteen years old, with irreversible pulpitis in one of the mandibular molars. Aggarwal’s study is used to determine the volume of the subjects which consisted of 165 patients. Some of the inclusion criteria are patients over 18 with irreversible pulpitis in one of the mandibular molars with normal radiographic view. Some of the exclusion criteria are existence of systemic diseases, allergy to Lidocaine with 1/80000 Epinephrine and widening of periodontal ligament. All the patients take a capsule 30 minutes before anesthesia. The capsules contain Placebo (Lactose) or 400 mg Iboprophen or 0.5 mg Dexamethasone. Then inferior alveolar nerve is blocked. After fifteen minutes, signs of soft tissue anesthesia will be evaluated. If the patient have no signs of anesthesia (s)he is excluded from the study. In patients with successful nerve block cold test and electric pulpal test will be carried out and pain scores are evaluated with VAS. The tooth will be isolated and access cavity will be prepared. If the patient has pain during access cavity preparation, pain during pulp chamber entrance or pulp canal entrance, pain will be measured with VAS. No pain or mild pain will be considered as success and other pain intensities as failure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011085141N1
Registration date:2012-04-02, 1391/01/14
Registration timing:na
Last update:
Update count:0
Registration date
2012-04-02, 1391/01/14
Registrant information
Name
Shahriar Shahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
shahis@tbzmed.ac.ir
Recruitment status
Not enough for processing
Funding source
Periodontal and dental research center, Tabriz university of medical sciences
Expected recruitment start date
2012-03-15, 1390/12/25
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Premedication of Ibuprofen and Dexamethasone on the Success of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis
Public title
Effect of Ibuprofen, dexamethasone and placebo on lower jaw nerve anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: healthy patients having a first or second mandibular molar tooth with irreversible pulpitis and normal periapical radiographic appearance. Exclusion criteria: the presence of systemic disorders, a sensitivity to lidocaine with 1:80,000 epinephrine; a sensitivity to NSAIDs; nasal polyp; a history of gastrointestinal ulcers; the presence of widening of the periodontal ligament space; the presence of a periapical radiolucency; lactation, pregnancy; using any type of analgesic medication in the preceding 12 hours before the treatment; having a tooth not suitable for restoration, and having a full crown.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
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 comitte of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
9072
Health conditions studied
1
Description of health condition studied
Irreversiblae pulpitis
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
inferior alveolar nerve block
Timepoint
45 minute after intervention (15 minute after injection)
Method of measurement
visual analoge scale
Secondary outcomes
1
Description
Analgesia during access cavity preparation and entrance into the root canal
Timepoint
during access cavity preparation and entrance into the root canal
Method of measurement
visual analoge scale
Intervention groups
1
Description
intervention group (Dexamethasone)
0.5 mg 30 min before injection
Category
Treatment - Drugs
2
Description
intervention groups (Ibuprofen )
400 mg 30 min before injection
Category
Treatment - Drugs
3
Description
control group (placebo: Lactose) 30 min before injection
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Periodontal and dental research center
Full name of responsible person
Prof. Reza Pourabbas
Street address
Faculty of dentistry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Periodontal and dental research center
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
Faculty of Dentistry
Full name of responsible person
Prof. Shahriar Shahi
Position
Professor of Endodontics
Other areas of specialty/work
Street address
Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 914 314 2971
Fax
Email
shahriar_shahi@yahoo.com , shahis@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Prof. Shahriar Shahi
Position
Professor of Endodontics
Other areas of specialty/work
Street address
Faculty of Denntistry
City
Tabriz
Postal code
Phone
+98 914 314 2971
Fax
Email
shahriar_shahi@yahoo.com , shahis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Prof. Shahriar Shahi
Position
Professor of Endodontics
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)