This study investigates whether sodium hypochlorite can alternative for Formocresol in pulpotomy of primary teeth.This randomized, double-blind, without control placebo,one central,stage one of clinical trial.30 children between four and nine years; healthy and cooperative each with at least two primary mandibular second molar requiring pulpotomy; were randomly allocated to two groups . All the teeth received stainless steel crown after conventional pulpotomy procedure with either sodium hypochlorite (applied for 15 second) or Formocresol (applied for 5 minute). Clinical and radiographic signs/symptoms recorded at six and 12 months.primary outcom: clinical success and secondary outcom: radiographic success
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015092717935N5
Registration date:2016-02-15, 1394/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-15, 1394/11/26
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Success Rate of sodium hypochlorite and formocresol for Primary Molar Teeth Pulpotomy
Public title
Comparison of Success Rate of two material in Primary Molar Teeth Pulpotomy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:primary molars with vital carious pulp exposures that
bled upon entering the pulp chambers,no clinical symptoms or evidence of pulp degeneration,
such as a history of spontaneous and nocturnal pain, pain on percussion, history of swelling, mobility, or sinus tracts,no radiographic signs of internal or pathologic external resorption and no furcation radiolucency,teeth would be restorable with posterior stainless steel crowns.exclusion criteria:uncooperative children.
Age
From 4 years old to 9 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
tabel randomied numerics
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
-
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
IR.SSU.REC.1394.107
Health conditions studied
1
Description of health condition studied
pulpotomy
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
clinical Success Pulpotomy
Timepoint
6 and 12 mounts after Pulpotomy
Method of measurement
clinical examination
Secondary outcomes
1
Description
radiographic success Pulpotomy
Timepoint
6 and 12 mounts after Pulpotomy
Method of measurement
observation radiography
Intervention groups
1
Description
Experimental group:0/5% sodium hypochlorite;applied for 30second
Category
Other
2
Description
Control group: Formocresol;1:5 Buckley’s solution;applied for 5minute
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Atefeh shakib
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Fateme Ezoddini Ardakani
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Dentistry FAaculty University of Medical Sciences,
Full name of responsible person
Atefeh Shakib
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
00983537267525
Phone
+98 983536250344
Fax
+98 35 3726 7525
Email
dratefehshakib@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr.Zahra Bahrololomi
Position
Associate professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
00983537267525
Phone
+98 983536250344
Fax
+98 35 3623 8561
Email
zbahrololoom@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Arefeh Shakib
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
00983536250344
Phone
+98 983536250344
Fax
+98 35 3726 7525
Email
dratefehshakib@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)