Comparative evaluation of postoperative pain in molar teeth with symptomatic irreversible pulpitis under going pulpotomy procedure after using MTA and Dexamethasone as pulp dressing agents.
This study designed to evaluate post operative pain in patients who need an urgent procedure for pain relief related to a symtomatic/vital molar tooth. after routine examination, voluntaries who have atleast one painful molar tooth will be included the trial and patients with other pulp statuses except irreversible pulpitis will be excluded.72 patients randomly divided in 3 groups; after preparation a standard acess cavity in painful tooth, one of the material( MTA or Dexamethasone) will be choosed randomly or a small dry cotton pellet also will be used as placebo or control group.
a Visual Analog pain Scale(VAS) will be used for evaluation of post-treatment pain in a 7 days period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030512708N1
Registration date:2013-06-03, 1392/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Hassan Shahabinejad
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9028
Email address
shahabi1386@gmail.com
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of postoperative pain in molar teeth with symptomatic irreversible pulpitis under going pulpotomy procedure after using MTA and Dexamethasone as pulp dressing agents.
Public title
Effect of MTA and Dexamethasone as pulp dressing agents on post-pulpotomy pain.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion Criteria:
painful and vital molar teeth;
normal periapical status
exclusion Criteria:
previously endodontic treatment on painful tooth;
usage of antibiotics or analgesics befor procedure;
pain in percussion or palpation;
pulp necrosis after access cavity preparation
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Jomhouri Eslami BOL.
City
Kerman
Postal code
Approval date
2012-01-25, 1390/11/05
Ethics committee reference number
k/90/321
Health conditions studied
1
Description of health condition studied
symptomatic irreversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
pulpitis(irreversible)
Primary outcomes
1
Description
post pulpotomy pain
Timepoint
6-12-18-24 hours and 2-3-4-5-6-7 days after treatment
Method of measurement
Visual Analog Pain Scale
Secondary outcomes
1
Description
number of Analgesics
Timepoint
7 days period
Method of measurement
number of analgesics will be used by patient for pain relief
Intervention groups
1
Description
intervention group (A) : a cotton pellet soaked with diluted MTA will be used as pulp dressing agent.
Category
Treatment - Other
2
Description
intervention group(B) : a small cotton pellet soaked with Dexamethasone will be used as pulp dressing agent.
Category
Treatment - Other
3
Description
control group: a small dry cotton pellet will be used as pulp dressing agent.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontics Department Of Kerman Dental School
Full name of responsible person
Dr. Hassan Shahabinejad
Street address
Kerman Dental School, Shafa street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oral Diseases Research CenterOf Kerman Dental School
Full name of responsible person
Dr.Arash Shahravan
Street address
Oral Diseases Research Center, Kovsar BOL.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oral Diseases Research CenterOf Kerman Dental School
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
Kerman Dental School
Full name of responsible person
Dr.Hassan Shahabinejad
Position
Assistant Proffessor
Other areas of specialty/work
Street address
Kerman Dental School, Shafa street
City
Kerman
Postal code
Phone
+98 34 1211 9025
Fax
Email
shahabi1386@gmai. com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Denatl School
Full name of responsible person
Dr.Hassan Shahabinejad
Position
Assistant Proffessor
Other areas of specialty/work
Street address
Kerman Dental School, Shafa street
City
Kerman
Postal code
Phone
+98 34 1211 9025
Fax
Email
shahabi1386@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr.Hassn Shahabinejad
Position
Assistant Proffessor
Other areas of specialty/work
Street address
Kerman Dental School, Shafa street
City
Kerman
Postal code
Phone
+98 34 1211 9025
Fax
Email
shahabi1386@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)