Forty patients with clinical signs and symptoms of irreversible pulpitis in one of their posterior mandibular teeth will enter the study upon completion of their medical history. Each patient will be randomly assigned to one of the study groups (the local anesthetic only group or the local anesthetic with ketamine group) and their primary pain score will be recorded. Each patient will recieve two dental cartridges injected with an inferior alveolar nerve block technique. The tooth will then be tested with a pulp tester and then a pulpectomy treatment will be carried out. Any pain experienced by the patient along with its stage will be recorded. The conventional treatment will be carried out for the patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905024440N1
Registration date:2010-10-11, 1389/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-11, 1389/07/19
Registrant information
Name
Vahid Sakhaei manesh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2869
Email address
sakhaei@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental School of Isfahan University of Medical Sciences
Expected recruitment start date
2010-08-01, 1389/05/10
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of anesthetic efficacy of combined local anesthetic and ketamine in patients with irreversible pulpitis in the posterior mandibular teeth
Public title
A comparison of anesthetic efficacy of combined local anesthetic and ketamine in patients with irreversible pulpitis in the posterior mandibular teeth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18-50 years, in healthy condition (ASA I or ASA II), having a posterior mandibular tooth (premolar or molar tooth) with a vital pulp and diagnosed as irreversible pulpitis, without severe periodontal disease, without any periapical pathological defect as seen in the radiograph of the tooth, without any contraindications for the drugs and substanses used in the study.
Exclusion criteria: Patients showing signs of pulp necrosis upon access cavity opening, patients showing any signs or symptoms of allergy or any adverse effects, patients refusing to continue at any stage point.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
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
Dental School Ethics Committee, Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research of Dental School, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
388485
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
Before and 15 minutes after administration of the local anesthetic
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Pulpal anesthesia
Timepoint
Before and 15 minutes after administration of the local anesthetic
Method of measurement
Pulp tester
Intervention groups
1
Description
Two dental cartridges of 2% Articaine combined with 20mg of Ketamine
Category
Treatment - Drugs
2
Description
Two dental cartridges of 2% Articaine combined with 0.2ml normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kaveh Dental Clinic
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Hezar Jarib Street
City
Isfahan
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 of Dental School, Isfahan 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
Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Vahid Sakhaei manesh
Position
Student of DDS course
Other areas of specialty/work
Street address
Dental School, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 936 552 1098
Fax
Email
sakhaei@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Endodontics, Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbasali Khademi
Position
MSc, Professor of Dental School, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 1792 2821
Fax
Email
a_khademi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Isfahan University of Medical Sciences
Full name of responsible person
Vahid Sakhaei manesh
Position
Student in a DDS course
Other areas of specialty/work
Street address
Isfahan Dental School, Isfahan University of Medical Sciences, HezarJarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 936 552 1098
Fax
Email
sakhaei@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)