Determination of the effect of ferric sulfate and formocresol on the clinical and radiographic success of pulpotomy in primary molars in 4-7 year-old children referring to the private clinic during 48 months follow up every 6 months
Design
In this research, 50 healthy children aged 4-7 year-old had a decayed primary molars on both sides of the upper or lower jaw were choosen purposefully and teeth were randomly divided in two control and intrvention groups
Settings and conduct
In this research, 50 healthy children aged 4-7 old had a decayed primary molars on both sides of the upper or lower jaw were choosen purposefully and teeth were randomly divided in two control and intervention groups.A pulpotomy technique is performed at a meeting by a pediatrician in a private clinic. In order to complete the pulpotomy in each side of the mouth, the patient should be randomly assigned to one session of sterilized cotton padded with formocresol for 5 minutes and another session with a ferric sulfate applicator for 30 seconds.
Participants/Inclusion and exclusion criteria
Entry conditions: 1)Having at least one decayed molar on each mandibular or maxillary jaw 2)Absence pulp degenaration(swelling,mobility,spontonous pain,sinus tract,fistula or abscess) 3)Absence radiographic symptomssuch as internal and external resorbtion, pathologic lesions in the forcation area,pulp stone,PDL widenning 4)Pulp exposure during caries removal 5)Can be restored with amalgam or SSC
Conditions of non-entry: primary molar with superficial caries
Intervention groups
In the intervention group, ferric sulfate and in the control group, formocresol is used
Main outcome variables
In this study evaluate the effect of ferric sulfate as a substitute of formocresol in treatment of primary molars.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161119030971N2
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Nahid Askarizadeh
Name of organization / entity
Dental branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21225645713
Email address
n_asgarizadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-22, 1396/11/02
Expected recruitment end date
2018-06-13, 1397/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of ferric sulfate & formocresol on clinical & radiographic success of primary molars pulpotomy -48 months follow up
Public title
primary molars pulpotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one decayed molar on each mandibular or maxillary jaw
Absence pulp degenaration(swelling,mobility,spontonous pain,sinus tract,fistula or abscess)
Absence radiographic symptomssuch as internal and external resorbtion, pathologic lesions in the forcation area,pulp stone,PDL widenning
Pulp exposure during caries removal
Can be restored with amalgam or SSC Conditions of non-entry
Exclusion criteria:
primary molar with superficial caries
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
decayed primary molar with pulpotomy treatment on either maxillary or lower jaw
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomized,randomized numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
the patient does not know which material is being used
the evaluator while clinical & radiographic evaluation does not know
Placebo
Not used
Assignment
Parallel
Other design features
Long term follow up
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشکده دندانپزشکی دانشگاه آزاد اسلامی تهران
Street address
Neyestan 10,Pasdaran,Tehran
City
tehran
Province
Tehran
Postal code
19585/175
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,34
Health conditions studied
1
Description of health condition studied
Evaluation the effect of ferric sulfate in treatment of pulpotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical success
Timepoint
6 months for 48 months
Method of measurement
clinical observation
2
Description
Radiographic success
Timepoint
6 months for 48 months
Method of measurement
Radiographic observation
Secondary outcomes
empty
Intervention groups
1
Description
In this group,ferric sulfate will be used once for 30 seconds.
Category
Treatment - Drugs
2
Description
Control group: diluted formocresol solution(1:5)(sultan inc) once for 5 minutes will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
مطب خصوصی
Full name of responsible person
دکتر ناهید عسکری زاده
Street address
NO. 81,West jamal Ave,Vafamanesh,Heravi Sq,Tehran Town
City
Tehran
Province
Tehran
Postal code
1437773578
Phone
+98 21 8805 3043
Email
Nahidaskarizadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private office
Full name of responsible person
دکتر ناهید عسکری زاده
Street address
NO. 81,West jamal Ave,Vafamanesh,Heravi Sq,Tehran Town
City
Tehran
Province
Tehran
Postal code
1437773578
Phone
+98 21 8805 3043
Email
Nahidaskarizdeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private office
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Private Office
Full name of responsible person
Dr Nahid Askarizadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
NO. 81,West jamal Ave,Vafamanesh,Heravi Sq,Tehran Town
City
Tehran
Province
Tehran
Postal code
1427773578
Phone
+98 21 8805 3043
Email
Nahidaskarizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Private office
Full name of responsible person
Dr Nahid Askarizadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
NO. 81,West jamal Ave,Vafamanesh,Heravi Sq,Tehran Town
City
Tehran
Province
Tehran
Postal code
1437773578
Phone
+98 21 8805 3043
Email
Nahidaskarizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Private office
Full name of responsible person
Dr Nahid Askarizadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
NO. 81,West jamal Ave,Vafamanesh,Heravi Sq,Tehran Town
City
Tehran
Province
Tehran
Postal code
1437773578
Phone
+98 21 8805 3043
Email
Nahidaskarizadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available