Aim: This randomized clinical trial –split mouth study investigated post-operative pain following use of mineral trioxide aggregate (MTA) and calcium enriched mixture (CEM) cement as pulp dressing biomaterials in vital pulpotomy of carious primary molars.
Materials and Methods: Forty-five children, aged 6-10 years, were included in this study. Each child had two cariously involved primary molar teeth in need of pulpotomy. Following caries removal and preparing access cavity in one of their carious teeth, either MTA or CEM were randomly used as pulpotomy agents, while their other carious primary molar teeth were capped with the other material. Then the teeth were permanently restored with stainless steel crown. Post-operative pain was recorded by child and the parents by using Wong-Baker faces pain rating scale during one week after operation.
General information
Acronym
CEM/MTA
IRCT registration information
IRCT registration number:IRCT2013091914712N1
Registration date:2014-11-17, 1393/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-17, 1393/08/26
Registrant information
Name
Hamideh Barghi
Name of organization / entity
Kerman University for Medical Sciences, Dental School.
Country
Iran (Islamic Republic of)
Phone
+98 34 5522 1319
Email address
h_barghi@collagain.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Oral and Dental Diseases Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2013-03-03, 1391/12/13
Expected recruitment end date
2013-11-20, 1392/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of post operative pain following Mineral trioxide aggregate and Calcium enriched material pulpotomy in primary molars
Public title
The effect of pulp dressing agents on post operative pain in children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary molar with out sign and symptom; same caries;no sensitivity to percussion; there is no pain except pain after eating; no clinical and radiographic evidence of pulp degeneration; Less than two-thirds of the root is involved; diseases that are not prescribed pulp therapy (leucemia).
Exclusion criteria: PA radiograph of a tooth is made and if there are any findings of internal analysis; thickening of the PDL; radiolucency; and calcified degeneration
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Oral and Dental Research Center
Street address
Kawthar blvd, Kerman
City
Kerman
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
k/91/267
Health conditions studied
1
Description of health condition studied
reversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
pulpitis
Primary outcomes
1
Description
Pain
Timepoint
1-7 days after treatment
Method of measurement
Wong-Baker faces pain rating scale.
Secondary outcomes
1
Description
post operative pain
Timepoint
from 1st to 7th day after treatment
Method of measurement
visual analogue scale (VAS)
Intervention groups
1
Description
interventiom group: use of CEM with standard pulpotomy method (2mm thickness)
Category
Other
2
Description
I nterventiom group: use of MTA with standard pulpotomy method (2mm thickness)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Univesity of Medical Sciences -School of Dentistry
Full name of responsible person
Hamideh Barghi,resident of pediatric dentistry
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
miss Hassani
Street address
Tahmasb abad cross, Kerman, Iran
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences-School of Dentistry.
Full name of responsible person
Hamideh Barghi
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1211 9021
Fax
Email
barghi.hamideh@gmail.commbarghi6@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences-School of Dentistry
Full name of responsible person
Dr Massoud Parrirokh
Position
Full Proffessor Endodontist
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1211 9021
Fax
Email
masoudparirokh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences- School of Dentistry
Full name of responsible person
Hamideh Barghi
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 1211 9021
Fax
Email
barghi.hamideh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)