Background and Aim: Formocresol is one of the most common pulpotomy medicament in the primary teeth. Because of its systemic and local side effects, it may be essential to use another material instead of formocresol. The purpose of this study was to assess pulpal changes of the pulp of primary teeth after pulpotomy with Sodium hypochlorite and formocresol
Methods and Materials: In this Randomized clinical trial, 22 teeth that must be extracted because of orthodontic treatment were selected. These teeth were divided randomly into 2 groups. 11 teeth were pulpotomized with formocresol and 11 teeth with Sodium hypochlorite. These teeth were extracted after 2 months and pulpal response was evaluated according to the degree of inflammation and extent of pulpal involvement. Dentinal bridge formation was also evaluated. Finally the data was analyzed with Mann Whitney test.
Key words: Formocresol- Histological evaluation- Pulpotomy- Primary teeth- Sodium hypochlorite
ted. These teeth were divided randomly into 2 groups. 11 teeth were pulpotomized with formocresol and 11 teeth with Sodium hypochlorite. These teeth were extracted after 2 months and pulpal response was evaluated according to the degree of inflammation and extent of pulpal involvement . Dentinal bridge formation was also evaluated. Finally the data was analyzed with mann withney test .
Key words: Formocresol- Histological evaluation- Pulpotomy- Primary teeth- Sodium hypochlorite
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901243316N3
Registration date:2010-05-30, 1389/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-30, 1389/03/09
Registrant information
Name
Roza Haghgoo
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 6227
Email address
haghgoo@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Dental School - Shahed University
Expected recruitment start date
2008-08-14, 1387/05/24
Expected recruitment end date
2009-02-20, 1387/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histopathological evaluation of pulp after pulpotomy of primary teeth with Sodium hypochlorite and formocresol
Public title
Histopathological evaluation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary canines that were healthy and must be extracted due to orthodontic treatment
Exclusion criteria: Root resorption more than one third
Age
From 7 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Committee of research centers- Between Forsat Str and Nosrat Str- Kargar Ave
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
46/2-2199
Health conditions studied
1
Description of health condition studied
Response of pulp of primary teeth
ICD-10 code
_
ICD-10 code description
_
Primary outcomes
1
Description
inflammation and abscess and necrosis , internal resorption and bridge formation
Timepoint
2 months
Method of measurement
Horsted etal scale
Secondary outcomes
empty
Intervention groups
1
Description
Pulpotomy with formocresol
Category
Treatment - Drugs
2
Description
Pulpotomy with Sodium hypochlorite
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dept of Pediatric Dentistry- Dental School- Shahed University
Full name of responsible person
Ms Kalantary
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center - betweem Forsat Str and Nosrat Str- Kargar Ave
Full name of responsible person
Dr Rezvani
Street address
Betweem Forsat Str and Nosrat Str- Kargar Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center - betweem Forsat Str and Nosrat Str- Kargar Ave
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
Research center- Dental School- Shahed University
Full name of responsible person
Mr Vafanoosh
Position
Master of Science
Other areas of specialty/work
Street address
Committee of Research center- Between Forsat Str and Nosrat Str- Kargar Ave
City
Tehran
Postal code
Phone
+98 912 607 0593
Fax
Email
sdntrc@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research center- Dental School- Shahed University
Full name of responsible person
Dr Rezvani
Position
Head of center / Assistant Prof
Other areas of specialty/work
Street address
Dept of Operative Dentistry- Dental School- Shahed University
City
Tehran
Postal code
Phone
+98 912 371 5066
Fax
Email
mbrezvani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)