Protocol summary

Study aim
To compare the clinical and radiographic differences of MTA and Garlic oil in pulpotomy of the first and second primary molars of children.
Design
All selected teeth were randomly divided into two groups each containing 45 samples , depending on the type of medicament used. Randomization was done by coin.
Settings and conduct
Shahed Dental School,Pediatric department
Participants/Inclusion and exclusion criteria
Inclusion criteria : These children were systemically healthy and had not used antibiotic in the last 14 days and had sufficient cooperation (Frankel 3 and 4), and on the strength of a complete history and clinical and radiographic examination , at least had two decayed asymptomatic primary molars, with the possibility of pulp exposure during cavity preparation.
Intervention groups
After topical gel , anesthesia was induce . All caries were removed. After rinsing with saline One or more sterile cotton pellets moistened with distilled water were placed over the pulp stumps, and gentle pressure was applied for 5 minutes for obtaining hemostasis. Randomly pulp stumps of molars in one side were dressed with a cotton pellet damped with Allium sativum oil ( Noshad company registeration number 1228208638 IRC ) for 1 minute. And on the other side MTA was used for 1 min. The access cavity was sealed with a thick mix of ZOE cement ( Kemdent) followed with SSC(3M) in proper size. Cementation was done with Glass inomer (GC1 Japan LUTING CEMNT)
Main outcome variables
The clinical success rate after 3 and 6 months was 100% in both groups . The radiographic success rates after 3 months and 6 months in the ALL group were 91.1% and 75.6 , respectively, and in the MTA group were 95.6% and 91.1%, respectively. The difference between the two groups was not statistically significant .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190313043046N1
Registration date: 2019-04-29, 1398/02/09
Registration timing: retrospective

Last update: 2019-04-29, 1398/02/09
Update count: 0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Taraneh Faghihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7571
Email address
trnfaghihi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-29, 1396/07/07
Expected recruitment end date
2018-09-29, 1397/07/07
Actual recruitment start date
2017-09-29, 1396/07/07
Actual recruitment end date
2018-09-29, 1397/07/07
Trial completion date
2018-09-29, 1397/07/07
Scientific title
Clinical and radiographical evaluation of Allium Sativum oil compared with MTA in primary molar pulpotomy in children
Public title
Clinical and radiographical evaluation of Allium Sativum oil compared with MTA in primary molar pulpotomy in children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
These children were systemically healthy at least Not used antibiotic in the last 14 days Had two decayed asymptomatic primary molars, with the possibility of pulp exposure during cavity preparation.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with table of random numbers unit of randomization individual
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and analyzer are blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethical Committee of Shahed University. (IR.Shahed.REC.1396.88 )
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.Shahed.REC.1396.87

Health conditions studied

1

Description of health condition studied
Clinical and radiographical evaluation of Allium Sativum oil in comparison with MTA in primary molar pulpotomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Clinical effect of Allium Sativum oil
Timepoint
Clinical and radiographical evaluation of Allium Sativum oil in comparison with MTA in primary molar pulpotomy in 3 and 6 months follow-up
Method of measurement
According to zurne and seale criteria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Randomly pulp stumps of molars in one side were dressed with a cotton pellet damped with allium sativum oil ( Noshad company registeration number 1228208638 IRC ) for 1 minute.
Category
Other

2

Description
Intervention group: After pulpotomy on the other side MTA was prepared according to manufacturer`s instructions and condensed lightly with a moistened sterile cotton pellet to ensure a thickness of 2 to 3 mm
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahed dental school
Full name of responsible person
Taraneh Faghihi
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
trnfaghihi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr Roza Haghgoo
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
haghgoodent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Taraneh faghihi
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
trnfaghihi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Taraneh faghihi
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
trnfaghihi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Taraneh Faghihi
Position
Resident of Pediatric Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental School, Shahed University, Italy St, Vesal Ave, Keshavarz Blv, Tehran, IR Iran
City
Tehran
Province
Tehran
Postal code
1417755351
Phone
+98 21 8895 9210
Email
trnfaghihi@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 results of the study would be identifed
When the data will become available and for how long
from summer 2019 they would be accessable
To whom data/document is available
for everyone
Under which criteria data/document could be used
no specific limitations
From where data/document is obtainable
trnfaghihi@gmail.com
What processes are involved for a request to access data/document
maximum 2 weeks after sending request to the email
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