Evaluation and comparison of the effectiveness of mineral trioxide aggregate and cold ceramic in the success of primary molars pulpotomy: a clinical and radiographic study
Evaluation and Comparison of Mineral Trioxide Aggregate and coldceramic in Primary Tooth Pulpotomy: Clinical and Radiographic Study
Design
Clinical trial with control group and intervention groups, with parallel, randomized groups, phase 4 on 42 patients
Settings and conduct
This clinical trial study was performed at Ahvaz Jundishapur University to compare the success of pulpotomy treatment of deciduous molars with cold ceramic and mineral trioxide aggregate in 42 children aged 4 to 9 years, each with two deciduous molars for treatment. The pulpotomy is performed with mineral trioxide aggregate and a glass ionomer light cure is placed on it and finally a metal crown is placed.
Then they are evaluated clinically and radiographically in 3 and 6 month follow-up.
Participants, outcome assessors, and the person responsible for data collection are not aware of the allocation of the intervention group.
The researcher is aware of the allocation of groups, but does not choose the material by himself.
Participants/Inclusion and exclusion criteria
General and mental health of the child
Lack of clinical adverse symptoms in the target tooth
Lack of adverse radiographic signs in the target tooth
Failure to refer the patient for 3 and 6 month follow-up
Having an underlying disease
Intervention groups
In the intervention group, cold ceramic material is used for primary molar pulpotomy.
In the control group, standard material mineral trioxide aggregate(mta) is used for primary molar palpotomy.
Main outcome variables
Evaluation of the success rate of primary molar pulpotomy with mineral trioxide aggregate
Evaluation of the success rate of primary molar pulpotomy with Coldceramic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220426054664N1
Registration date:2022-05-31, 1401/03/10
Registration timing:prospective
Last update:2022-05-31, 1401/03/10
Update count:0
Registration date
2022-05-31, 1401/03/10
Registrant information
Name
Bita Rasteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4352 4848
Email address
bitarasteh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effectiveness of mineral trioxide aggregate and cold ceramic in the success of primary molars pulpotomy: a clinical and radiographic study
Public title
Coldceramic in primary Tooth Pulpotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General and mental health of the child
Lack of clinical adverse symptoms in the target tooth such as spontaneous pain or nocturnal pain, swelling of pulpal origin, pathological sagging, fistula
Lack of adverse radiographic signs of the desired tooth such as internal root resorption, external root resorption and periapical or furca area
Exclusion criteria:
Failure to refer the patient for 3 and 6 month follow-up
Having an underlying disease
Age
From 4 years old to 9 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
One primary molar pulpotomy with mineral trioxide aggregate and another primary molar in the same person pulpotomy with Coldceramic
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants enter the study with their consent but do not know each tooth with which material was pulpotomized.
The clinical caregiver treats primary pulpotomy but is unaware of the type and purpose of the study.
Evaluators evaluate the clinical outcome and radiographs of treated teeth. They know the purpose of the study , but they do not know the type of material used for each pulpotomy treatment and group assignment.
The person responsible for collecting the data is also unaware of the type of intervention and the type of substance used to treat the pulpotomy and to assign groups.
Data analysts are aware of the type of intervention and group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
No:14، Damavand7 building، Esfahan، Dey Street
City
Ahwaz
Province
Khouzestan
Postal code
6381944814
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
IR.AJUMS.REC.1400.589
Health conditions studied
1
Description of health condition studied
pulpotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Success of pulpotomy treatment
Timepoint
Follow-up 3 and 6 months after treatment
Method of measurement
Radiographs and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment of primary molar pulpotomy with cold ceramic , which is made in Iran and contains compounds of calcium oxide, silicon acid, these compounds are 93% of its components. Other components include MgO, MnO, Fe2O3, Na2O, K2O and TiO2. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the cold-ceramic powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair
Category
Treatment - Drugs
2
Description
Control group: Treatment of primary molar pulpotomy with mineral trioxide aggregate, Made in Iran and contains compounds of tricalcium silicate, dicalcium silicate, tricalcium aluminate, tetracalcium aluminophyte, calcium sulfate and bismuth oxide. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the mineral trioxide aggregate powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Jundishapur University
Full name of responsible person
Bita Rasteh
Street address
No:14، Damavand7 building، Esfahan، Dey Street
City
Ahwaz
Province
Khouzestan
Postal code
6381944814
Phone
+98 61 4352 4848
Email
Bitarasteh99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bita Rasteh
Street address
No:14 ، Damavand7 building، Esfahan، Dey street
City
Ahwaz
Province
Khouzestan
Postal code
6381944814
Phone
+98 61 4352 4848
Email
Bitarasteh99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Bita Rasteh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.14, damavand 7 building, Esfahan, Dey street
City
Ahwaz
Province
Khouzestan
Postal code
6381944814
Phone
+98 61 4352 4848
Fax
Email
bitarasteh99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bita Rasteh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.14, damavand 7 building, Esfahan, Dey street
City
Ahvaz
Province
Khouzestan
Postal code
63819448114
Phone
+98 61 4352 4848
Fax
Email
bitarasteh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bita Rasteh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.14, damavand 7 building, Esfahan, Dey street
City
Ahvaz
Province
Khouzestan
Postal code
63819448114
Phone
+98 61 4352 4848
Fax
Email
bitarasteh99@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
Evaluation and Comparison of Mineral Trioxide Aggregate and coldceramic in Primary Tooth Pulpotomy: Clinical and Radiographic Study
When the data will become available and for how long
Start the access period at the same time as printing the results
To whom data/document is available
for everyone
Under which criteria data/document could be used
کو
From where data/document is obtainable
bitarasteh992@gmail.com
What processes are involved for a request to access data/document
Send the request via email and receive a response within a month