Comparison of pulpotomized primary molar teeth using Calcium-Enriched Mixture and Ferric sulfate clinically and radiographically in children: a randomized clinical trial
Comparison of clinical and radiographic success rate and pain after pulpotomy in primary molars using Calcium-Enriched Mixture (CEM) cement and Ferric sulfate
Design
Clinical trial with intervention groups, with parallel, two-way blind and randomized groups on 24 patients. Simple randomization method (flip the coin) will be used to randomize.
Settings and conduct
This project will be carried out in the Department of Pediatrics of the Kerman Dentistry School. Before treatment, the patient becomes aware completely of two types of material used for treatment, but he/she does not know which substance is used for her/his tooth during treatment. Follow up evaluations are carried out by two researchers who are not aware of the type of treatment and they will comment on radiographic criteria. The statistician is not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pulp exposure due to caries; restorable teeth with stainless steel crown; hemostasis could be easily achievable.
Non inclusion criteria: pathologic mobility; history of spontaneous pain; sinus tracts; abscess or swelling; internal or pathologic external root resorptionan; interradicular or periapical radiolucency.
Intervention groups
Intervention group 1: CEM cement. This material is combined according to the manufacturer's instructions and placed on the pulp.
Intervention group 2: Ferric sulfate. 15.5% ferric sulfate is placed on the pulp for 15 seconds. It is then washed and zonalin base is placed in the pulp chamber.
Main outcome variables
Internal resorption; dental abscess and fistula
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171020036896N8
Registration date:2020-06-26, 1399/04/06
Registration timing:registered_while_recruiting
Last update:2020-06-26, 1399/04/06
Update count:0
Registration date
2020-06-26, 1399/04/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pulpotomized primary molar teeth using Calcium-Enriched Mixture and Ferric sulfate clinically and radiographically in children: a randomized clinical trial
Public title
Clinical and radiographic success and pain after pulpotomy treatment using Calcium-Enriched Mixture and Ferric sulfate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pulp exposure due to caries
Restorable teeth with stainless steel crown
Hemostasiscould be easily achievable
Exclusion criteria:
Pathologic mobility
History of spontaneous pain
Sinus tracts , abscess or swelling
Internal or pathologic external root resorptionan
Interradicular or periapical radiolucency
Age
From 3 years old to 9 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple randomization method (flip the coin) will be used. In such a way that one of the study groups will be considered as heads and the other group will be considered as tails. Then the same number of coins will be thrown based on the sample size. Finally, to prevent disclosure of random sequencing, the allocation concealment will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before treatment, the patient becomes aware completely of two types of material used for treatment, but he/she does not know which substance is used for her/his tooth during treatment. Follow up evaluations are carried out by two researchers who are not aware of the type of treatment and they will comment on radiographic criteria. The statistician is not aware of the type of treatment.
Placebo
Not 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
Shafa avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
IR.KMU.REC.1393.538
Health conditions studied
1
Description of health condition studied
Pulpitis
ICD-10 code
Pulpitis
ICD-10 code description
Pulpits
Primary outcomes
1
Description
Internal resorption
Timepoint
6 months after the start of intervention
Method of measurement
Through radiographic examination
2
Description
Dental abscess and fistula
Timepoint
6 months after the start of intervention
Method of measurement
Through clinical examination
Secondary outcomes
1
Description
External resorption
Timepoint
6 months after the start of the intervention
Method of measurement
Through radiographic examination
2
Description
Furcation radiolucency
Timepoint
6 months after the start of the intervention
Method of measurement
Through radiographic examination
Intervention groups
1
Description
Intervention group 1: After pulpotomy, the CEM cement was prepared according to the manufacturer's instructions and placed in the pulp chamber.
Category
Treatment - Drugs
2
Description
Intervention group 2: a cotton ball impregnated by ferric sulfate 15.5% was placed on the orifices of canals for 15 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Farzaneh Jalalih
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fznjalali@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Shafa avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fznjalali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh Jalali
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fznjalali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh Jalali
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fznjalali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh Jalali
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fznjalali@gmail.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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available