Comparison of the analgesic effect of odontopaste and a medicament with similar formulation in pain control after emergency treatment in the patients with lower posterior tooth pain
The aim of this study is to make a medicament similar to odontopaste that The use of this medicament between appointment may help to relieve the pain during and after root canal treatment.This randomized control trial will be done on 90 patients (with age range between 18 and 35 years old ) that are referred to the endodontic department of ahwaz dental faculty at 2011-2012.
Patients appoint their pain rate (also percussion sensitivity) on heft-parker VAS diagram,at the beginning of any appointment.Patients was be put under anesthesia then the radicular and coronal pulp was emit.Patients was entered to one of the intervention groups or control group by randomized table.
Group1:Patients that their canals was dressed by new intracanal medicament .
Group2 :Patients that their canals was dressed by odontopaste medicament.
Group3 :Patients that their canals was dressed by placebo
Access cavity was covered by cavisol at 1 week interappointment.Patients determine their pain rate on VAS diagram,24 hours after the first appointment.In the beginning of the second appointment patients determine their pain rate on VAS diagram.Considerable, the patient, clinician and analyst are blind and this study is tri-blind.Also said to patient that does not use analgesic medicine at interappointment.
General information
Acronym
AES
IRCT registration information
IRCT registration number:IRCT201110196443N2
Registration date:2012-11-17, 1391/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-17, 1391/08/27
Registrant information
Name
Behrouz Eftekhar
Name of organization / entity
Ahwaz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 1643
Email address
eftekhar-b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University Of Medical Science
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of odontopaste and a medicament with similar formulation in pain control after emergency treatment in the patients with lower posterior tooth pain
Public title
Comparison of the analgesic effect of odontopaste and a medicament with similar formulation between root canal therapy appointments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The spontaneous pain or sensitivity to percussion before treatment;The tooth should be first or second molar;the patient should be without any systemic problem, female should not be pregnant or in lactating stage;The patients do not have any history of oral diseases or hypersensitivity to antibiotics or corticosteroid;The tooth should have a normal apex;The roots were without resorption and pathological problems such as periapical lesions;The patients were not be used NSAIDs medicine 1 hour before treatment.
Exclusion criteria:
If the patient has severe pain,is exclude from seven days evaluation and prescribe analgesic;The patient has not be satisfied to continue in study;If the patient did not confer seven days later;The procedure accidents;If the pain rate did not record at 24 hours after the first appointment;If the patient used analgesic.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
َhwaz University Of Medical Science
Street address
Dy st, Frvardin blv, Glestan,Awaz
City
Awaz
Postal code
Approval date
2012-07-29, 1391/05/08
Ethics committee reference number
1911//د/20/8/پ
Health conditions studied
1
Description of health condition studied
Toothache
ICD-10 code
K08.8
ICD-10 code description
Toothache NOS
2
Description of health condition studied
Acute apical periodontitis
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis NOS
Primary outcomes
1
Description
Toothache
Timepoint
Before first appointment-24 hours after intracanal medicament insertion-7 days after intracanal medicament insertion
Method of measurement
Use of VAS diagram
2
Description
Acute apical periodontitis
Timepoint
Before first appointment-24 hours after intracanal medicament insertion-7 days after intracanal medicament insertion
Method of measurement
Use of VAS diagram
Secondary outcomes
empty
Intervention groups
1
Description
Intracanal medicament insertion
Category
Treatment - Drugs
2
Description
Intracanal medicament similar to odontopaste containing clindamycin and triamcinolone insertion
Category
Treatment - Drugs
3
Description
Placebo containing ethyle cellolose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Ahwaz University Of Medical Science
Full name of responsible person
Behrooz eftekhar
Street address
Dey A, Farvardin BLV, Golestan
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research assistance Of Ahwaz University Of Medical Science
Full name of responsible person
Mohammad Reza Abbas Pour
Street address
1th floor, Research assistance, university city
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistance Of Ahwaz University Of Medical Science