Comparison of clinical and radiographic success rates of Pulpotomy in primary molars using formocresol, Portland cement and NeoMTA Plus: a double-blind randomized clinical trial
Comparison of clinical and radiographic success rates of Pulpotomy in primary molars using formocresol, Portland cement and NeoMTA Plus: a double-blind randomized clinical trial
Design
A Clinical trial with control, interventional, blind, and randomized groups with a parallel group design of 96 primary molar teeth
Settings and conduct
This study was performed on 96 primary molars in healthy children aged 3 to 9 years who had referred to the pediatric dental office for dental treatment. Treatment with three substances such as formocrozole, Portland cement and NeoMTA Plus was performed by a pediatric dentist in a pediatric dental office. In this study, follow-up evaluations were performed in radiographic and clinical aspects at least 12 months after calibration. , Two researchers who are not aware of the type of treatment comment on radiographic criteria. In case of disagreement between them, a single conclusion will be reached by discussing the disputed samples.
Participants/Inclusion and exclusion criteria
Pulp exposure due to caries؛ No pathologic mobility؛ No history of spontaneous pain؛ No sinus tracts, abscess or swelling؛ Restorable teeth with stainless-steel crown؛ Hemostasis could be easily achievable؛ No internal or pathologic external root resorption؛ No interradicular or periapical radiolucency
Intervention groups
Group 1: Portland Cement ؛ Group 2: NeoMTA Plus
Main outcome variables
Mutation and cytogenic effect of formocresol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039763N5
Registration date:2022-03-14, 1400/12/23
Registration timing:registered_while_recruiting
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Fatemeh Jahanimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8071
Email address
jahanimoghadam@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-24, 1400/12/05
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and radiographic success rates of Pulpotomy in primary molars using formocresol, Portland cement and NeoMTA Plus: a double-blind randomized clinical trial
Public title
Comparison of clinical and radiographic success rates of Pulpotomy in primary molars using formocresol, Portland cement and NeoMTA Plus: a double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pulp exposure due to caries
No pathologic mobility
No pain in percussion
No history of night pain
No sinus tracts, abscess or swelling
Restorable teeth with ssc
Hemostasis could be easily achievable
No internal or pathologic external root resorption
No interradicular or periapical radiolucency and Periodontal ligament widening
Exclusion criteria:
Existence of any systemic disease such as leukemia that the child can not be treated with pulp therapy
internal or pathologic external root resorption
Periodontal ligament widening
interradicular or periapical radiolucency
If more than two thirds of the root length has undergone physiological resorption
Blockage of the pulp canals
Age
From 3 years old to 9 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
Given that external factors, such as age and/or gender, are not affected by the outcome (clinical and radiographic success rate) there is no need for advanced randomization such as minimization. In addition, a therapist will perform all pulpotomies to eliminate the role of the therapist.Therefore, individuals in this study, using simple randomization and random numbers are entered into three groups of study.
Blinding (investigator's opinion)
Double blinded
Blinding description
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 Ave
City
kerman
Province
Kerman
Postal code
7618759689
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.KMU.REC.1400.223
Health conditions studied
1
Description of health condition studied
pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Mutation and cytogenetic formocresol
Timepoint
12 month later
Method of measurement
Through clinical and radiographic evaluation and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Cotton pellet impregnated with formocresol (sultan, USA) is placed on the pulp for 5 minutes
Category
Treatment - Drugs
2
Description
Intervention group: 1: After pulp tissue homeostasis, Portland cement (Votoran; SãoPaulo, SP, Brazil) is mixed according to the manufacturer's instructions and placed in thepulp chamber. 2: After pulp tissue homeostasis, NeoMTA Plus material (Avalon Biomed Inc. (Bradenton, FL, USA) is combined according to the manufacturer's instructions and will be placed in the pulp chamber .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric dental office
Full name of responsible person
Pouya Karimipour Fard
Street address
Esteghlal Avenue
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3243 4768
Email
pouyakm1996@gmail.com
2
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Pouya Karimipour Fard
Street address
Shafa Avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
pouyakm1996@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 9021
Email
pouyakm1996@gmail.com
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
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
Pouya Karimipour Fard
Position
Doctor of dental surgery student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shafa Avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
pouyakm1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pouya Karimipour Fard
Position
Doctor of dental surgery student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
shafa avenue
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
pouyakm1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pouya Karimipour Fard
Position
doctor of dental surgery student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
shafa avenue
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
pouyakm1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a portion of the data is shared, such as the original outcome information.
When the data will become available and for how long
Start the access period, 6 months after printing the results.
To whom data/document is available
Only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For researchers
From where data/document is obtainable
pouyakm1996@gmail.com
What processes are involved for a request to access data/document