The aim of this clinical trial study is the comparing of postoperative endodontic pain in 60 mandibular molars on 2013-14. Therefore a successful management of endodontic pain has become as one of the main dental objectives. The aim of the present study was to compare the postoperative endodontic pain in patients under general anaesthesia versus local anaesthesia.
This study will be performed on a format of clinical trial on 60 patient. First and second mandibular molars with symptomatic pulpits will be selected. 30 patients will be treated under general anaesthesia because of their fear, anxiety, or gag reflex. other 30 patients will be treated under local anaesthesia.This treatments no requires the patient's randomization. All teeth will be prepared using engine-driven rotary system in a Crown-down technique and fill using Lateral Condensation technique. Heft- Parker Visual Analog Scale will be used to measure the degree of pain at 6, 12,24and 48 hours after the treatment. The outcome will be assessed using variant analysis method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061013619N1
Registration date:2013-09-07, 1392/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Ghader Feizi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2812
Email address
feizi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Postoperative Endodontic Pain in 60 lower molars under General Anaesthesia versus Local Anaesthesia
Public title
Clinical evaluation of the general and local anesthesia techniques on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
( Inclusion criteria: age 60-20 years; no history of systemic diseases; especially lower molars with irreversible pulpitis)
( Exclusion criteria: history of a systemic disease; lack of anesthesia; the anesthesia group )
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
University of Medical Sciences
City
Isafahn
Postal code
8174673461
Approval date
2012-10-15, 1391/07/24
Ethics committee reference number
392072
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04
ICD-10 code description
pulpitis-irreversible
Primary outcomes
1
Description
Degree of Pain
Timepoint
2,6,12,24 and 48 hours after procedure
Method of measurement
Visual Analogues Scale
Secondary outcomes
1
Description
prolonged recovery time
Timepoint
1,2,4,8 h
Method of measurement
Level of alertness and reaction to stimulates
Intervention groups
1
Description
Patients will divided into two groups. In the first experimental group anesthesia will take in less than 2 hours. Requires the injection of drugs were as follows: Patients induction will perform using / kg mg 5 thiopental sodium (Nani Pharmaceuticals, India) and μg / Kg 1 Fentanyl (Aboureihan, Tehran, Iran) and mg / Kg 4/0 Atracurium (Aboureihan, Tehran, Iran) and will attach to Dragr anesthesia machine (Drager, Fabius, Germany) according to the setting of weights. Anesthesia maintain will perform with 50% oxygen (gas medicine, Isfahan, Iran) and nitrous oxide 50% (clinic, Isfahan, Iran). Also, after treatment with drugs will inject into the muscle relaxation Reverse mg / kg 4/0 neostigmine (drug Alborz - Iran) and mg / kg 2/0 atropine (Daroupakhsh - Iran), the patient will awaken and transfer to the recovery room.
Category
Treatment - Other
2
Description
we have not applicable in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitalized Dentistry
Full name of responsible person
Ghader Feizi
Street address
Torabinejad Dental Research Center-Faculty of Dentistry - Isfahan University of Medical Sciences- St. Hezarjarib
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Dr.Omid Savabi
Street address
Department of Research and Technology, Building No. 4, Central Organ Of University,Isfahan university of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
392072
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Isfahan university of Medical Sciences
Full name of responsible person
Dr. Ghader Feizi
Position
Endodontist
Other areas of specialty/work
Street address
Faculty of dentistry, Isfahan university of Medical Sciences,Hezar Jerib St.