Assessment and comparison of pain relief effect of three intracanal medicament after cleaning and shaping of tooth root canal.
Design
Three blinded randomized trial (randomized by random number table) which will conduct to compare pain relieving effect of three root canal medicaments.
Settings and conduct
Patients referring to office of the conductor dentist of the study are the target group. Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant
Participants/Inclusion and exclusion criteria
inclusion criteria: without any systemic diseases, molar or premolar tooth with necrotic pulp, permanent and closed apex tooth, tooth shouldn't have any kind of resorption and patient should not use any NSAIDS in last three hours before treatment.
exclusion criteria: patient won't come for the following treatment appointment, patient doesn't prefer to collaborate and don't complete the pain in the charts by the patient.
Intervention groups
this study includes three case groups: treatment will done by mixture of "calcium hydroxide and %0/9 normal saline", "calcium hydroxide and %2 Chlorhexidine" and "calcium hydroxide and dexamethasone (8mg/2cc)". after cleaning and shaping one of these mentioned medicament will apply in root canal for comparison of their pain relieving effect.
Main outcome variables
inter appointments pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039766N1
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2018-06-25, 1397/04/04
Update count:1
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Arash Ghanbarzadegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 0378
Email address
arash.ghanbarzadegan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Efficacy of Intracanal Medicaments on Tooth Root Canal Treatment Pain Management
Public title
Intracanal Medicaments and Root Canal Treatment Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
without any systemic diseases
molar or premolar tooth with necrotic pulp
permanent and closed apex tooth
tooth shouldn't have any kind of resorption
patient should not use any NSAIDS in last three hours before treatment
Exclusion criteria:
patient won't come for the following treatment appointment
patient doesn't prefer to collaborate
don't complete the pain in the charts by the patient
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
patient will be select by random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient, dentist and statistical analyzer will be blinded and drugs will be prepared and given to the dentist by the dental assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.AJAUMS.REC.1397.005
Health conditions studied
1
Description of health condition studied
inter appointments pain after cleaning and shaping of root canal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
inter appointments pain after cleaning and shaping of tooth root canal
Timepoint
4 hours after treatment, the first day, the second day, the third day and the fourth day.
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treated by mixture of calcium hydroxide and %0/9 normal saline.
Category
Treatment - Drugs
2
Description
Intervention group: treated by mixture of calcium hydroxide and %2 Chlorhexidine.
Category
Treatment - Drugs
3
Description
Intervention group: treated by mixture of calcium hydroxide and dexamethasone (8mg/2cc).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali- Asr clinic
Full name of responsible person
Arash Ghanbarzadegan
Street address
Meimand entrance St
City
Meimand
Province
Fars
Postal code
7134798156
Phone
+98 71 3877 2007
Email
arash.ghanbarzadegan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Mostafa Shahrezaei
Street address
Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6351
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Researcher Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Baran Building, 12th Ave., Faghihi St., Zand Blvd.
City
shiraz
Province
Fars
Postal code
7134798156
Phone
+98 71 3235 0378
Email
Arash.ghanbarzadegan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Dental researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moalem st. aja dental school, endodontics department
City
Tehran
Province
Tehran
Postal code
7134798156
Phone
+98 71 1235 0378
Fax
Email
arash.ghanbarzadegan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Arash Ghanbarzadegan
Position
Dental researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moalem st. aja dental school, endodontics department
City
Tehran
Province
Tehran
Postal code
7134798156
Phone
+98 71 1235 0378
Fax
Email
arash.ghanbarzadegan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available