Comparison of clinical and radiographic success rate and pain after pulpotomy in primary molars using standardized extract of myrtle (Myrtus communis L.) leaves and formocresol: a double blind randomized clinical trial
Comparison of clinical and radiographic success rate and pain after pulpotomy in primary molars using standardized extract of myrtle (Myrtus communis L.) leaves and formocresol: a double blind randomized clinical trial
Design
Clinical trials with control, interventional, blind, and randomized control groups
Settings and conduct
This project will be carried out in the Department of Pediatrics of the Kerman School of Dentistry. Before treatment, adequate explanations will be given on the clinical approach and treatment logic as well as possible risks to the parents. Pulpotomy treatment of all teeth will be done by a specialized dentistry assistant and supervised by the relevant teacher. Follow up evaluations are carried out by two researchers who are not familiar with the type of treatment and will comment on radiographic criteria.
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 ssc , hemostasiscould be easily achievable, No internal or pathologic external root resorptionan, No interradicular or periapical radiolucency
Intervention groups
Group 1: Formocresol
Group 2: Myrtus Extract
Main outcome variables
Mutation and cytogenic effect of formocresol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039725N1
Registration date:2018-12-06, 1397/09/15
Registration timing:registered_while_recruiting
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
fatemeh mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3638 3952
Email address
fa.mohamadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and radiographic success rate and pain after pulpotomy in primary molars using standardized extract of myrtle (Myrtus communis L.) leaves and formocresol: a double blind randomized clinical trial
Public title
Comparison of clinical and radiographic success rate and pain after pulpotomy using standardized extract of myrtle (Myrtus communis L.) leaves and formocresol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pulp exposure due to caries, no pathologic mobility, No history of spontaneous pain , no sinus tracts , abscess or swelling, Restorable teeth with ssc , hemostasiscould be easily achievable, No internal or pathologic external root resorptionan, No interradicular or periapical radiolucency
Exclusion criteria:
Age
From 5 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Through the random numbers table
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 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
2018-12-03, 1397/09/12
Ethics committee reference number
IR.KMU.REC.1397.322
Health conditions studied
1
Description of health condition studied
pulp disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mutation and cytogenic effect of formocresol
Timepoint
0,6,12 month
Method of measurement
radiographic and clinical finding , and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1: Cotton impregnated with Formocresol (Sultan, USA) for 5 minutes Group 2: Cotton impregnated with Myrtus extract for 30 Min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
fatemeh mohammadi
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
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
2
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
abbas pardakhti
Street address
shafa
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
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
fatemeh mohammadi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
fatemeh mohammadi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
fatemeh mohammadi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fa.mohamadi@kmu.ac.ir
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 part of the information, such as the original outcome information, is shared.
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
-
From where data/document is obtainable
f.mohammadi4045@gmail.com
What processes are involved for a request to access data/document