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Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Amene Taghdisi
Full name of responsible person - Persian: دکتر آمنه تقدیسی
Street address - English: Kashan University of Medical Sciences, Kashan, Iran
Street address - Persian: دانشگاه علوم پزشکی کاشان، کاشان ، ایران
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 31 5554 0021
Fax:
Email: ataghdisi@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Faeze Mirjalili
Full name of responsible person - Persian: دکتر فائزه میرجلیلی
Street address - English: Kashan University of Medical Sciences, Kashan, Iran
Street address - Persian: دانشگاه علوم پزشکی کاشان، کاشان ، ایران
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715973474
Phone: +98 31 5554 0021
Fax:
Email: drfaezemirjalili@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Amene TaghdisiFaeze Mirjalili Full name of responsible person - Persian: دکتر آمنه تقدیسیفائزه میرجلیلی Street address - English: Kashan University of Medical Sciences, Kashan, Iran Street address - Persian: دانشگاه علوم پزشکی کاشان، کاشان ، ایران City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8715973474 Phone: +98 31 5554 0021 Fax: Email: ataghdisidrfaezemirjalili@yahoo.com Web page address:
Protocol summary
Study aim
Comparison of clinical and radiographic outcome between diode980nanometerms laser pulpotomy and formocresol pulpotomy in primary molar teeth during 6 and 12 months follow up.
Design
In this research,a total of 22 healthy children with an average age of 2-10 years-old had two primary molars in two quadrants need to be pulpotomy were selected and teeth were randomly divided in two control and intervention groups
Settings and conduct
A pulpotomy technique is performed by a pediatrician in a private clinic. In order to complete the pulpotomy, the selected teeth of each patient should be randomly divided two group.in group one, a sterilized cotton pad with formocresol is placed on canal orifices for 5 minutes, in group two the diode980nm laser is radiated into canal orifice using a specialized handpiece for 5 seconds, and after pulp color changed ,pulp chamber is gently filled by 2 mm of reinforced ZOE and then the tooth is restored. Results of clinical evaluations and periapical radiographies of the 6th and 12th months will be recorded and compared.
Participants/Inclusion and exclusion criteria
1)Selected children should not have high-risk and underlying disease or contraindications to pulp treatment
2)Children with an average age of 2 to 10 years who having at least two primary molar teeth in two quadrants need to be pulpotomy
3)Teeth should not have necrotic pulp, swelling, mobility, spontaneous pain ,sinus tract ,fistula or abscess
4)Absence radiographic symptoms such as internal and external root resorption, pathologic lesions in the furcation and periapical area, pulp stone, PDL widening، loss of lamina dura
5)Pulp exposure during caries removal
6)Can be restored with amalgam or SSC
Intervention groups
In one intervention group,diode 980nms laser and in the other intervention group, formocresol is used
Main outcome variables
Clinical success; Radiograghic success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210311050676N1
Registration date:2021-03-21, 1400/01/01
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:1
Registration date
2021-03-21, 1400/01/01
Registrant information
Name
Amene Taghdisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
ataghdisi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-25, 1400/01/05
Expected recruitment end date
2021-03-28, 1400/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical and radiographic outcome between diode980nanometerms laser pulpotomy and formocresol pulpotomy in primary molars
Public title
Evaluation of the effect of Diode 980 nm laser on the success of deciduous teeth pulpotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Selected children should not have high-risk and underlying disease or contraindications to pulp treatment
Children with an average age of 2 to 10 years who having at least two primary molar teeth in two quadrants need to be pulpotomy
Teeth should not have necrotic pulp،swelling ,mobility ,spontaneous pain ,sinus tract ,fistula or abscess
Absence radiographic symptoms such as internal and external root resorption, pathologic lesions in the furcation and periapical area،,pulp stone،,PDL widening،loss of lamina dura
Pulp exposure during caries removal
Can be restored with amalgam or SSC
Exclusion criteria:
primary molar teeth with superficial caries
Teeth that fall out soon
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
Two
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants don't know which teeth have been treated with laser and which teeth have been treated with formocresol
The doctor who performs treatment, know which teeth have been treated with laser and which teeth have been treated with formocresol
Responsible for data collection and analysis don't know which teeth have been treated with laser and which teeth have been treated with formocresol
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan university of medical sciences
Street address
Kashan University of Medical Sciences, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.013
Health conditions studied
1
Description of health condition studied
Vital pulp therapy in primary teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical success rate of treatment
Timepoint
6th and 12th month
Method of measurement
clinical observation of teeth
2
Description
Radiographical success rate of treatment
Timepoint
6th and 12th month
Method of measurement
periapical radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pulpotomy with formocresol, In this group, cotton soaked in diluted formocresol (1: 5) of master dent is placed on each orifice for 5 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: pulpotomy with DIODE980nm laser, In this group, pulpotomy with diode 980 nm laser from company nu smile simpler 2, at a distance of 1 mm from the orifice is continuously irradiated by a fiber optic with a diameter of 320 μm for 5 seconds and applied non-contact on each orifice, which if coagulation is observed Blood decreases this time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Private office
Full name of responsible person
Dr Amene Tghdisi
Street address
Kashan, Beheshti Street, Goli Alley
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5557 0802
Email
ataghdisi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Faeze Mirjalili
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
drfaezemirjalili@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr Amene Taghdisi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric dentist
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
ataghdisi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Amene Tghdisi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric dentist
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
ataghdisi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Ghasemi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
fahimehghasemi9797@yahoo.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