Protocol summary

Summary
Introduction and Background: Formocresol is a popular pulpotomy medicament in the primary dentition. Because of its systemic and local side effect, it may be essential to use another material instead of formocresol. Objectives: The purpose of this study was to assess the histological pulpal response after pulpotomy with two different agents: formocresol and SUAB2. Design: This study was a randomized clinical trial study. Setting and conduct: In this study pulpotomy was done with formocresol and SUAB2. Participants: 14 teeth of 7 children that must be extracted due to orthodontic treatment were selected. Inclusion criteria: children who were 7-8 years and otherwise healthy and had the canines that were sound and must be extracted due to orthodontic treatment Intervention: These teeth were divided randomly into 2 groups: formocresol and SUAB2. 7 teeth were pulpotomized with SUAB2 (a herbal prepration, 5 minutes, 1 time) and 7 teeth with formocresol (1.5, DENTSPLY/ a French company, 5 minutes, 1 time). These teeth were extracted after 2 months and pulpal response inflammation, abscess, internal resorption, fibrosis, necrosis, and dentinal bridge formation) was evaluated. Finally the data was analyzed using mann-withney and fisher exact tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901243316N4
Registration date: 2010-12-30, 1389/10/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-30, 1389/10/09
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, Shahed university Dental School
Expected recruitment start date
2009-07-12, 1388/04/21
Expected recruitment end date
2010-04-20, 1389/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Histological evaluation of the pulp of primary teeth after pulpotomy with formocresol and SUAB2
Public title
Evaluation of pulp after pulpotomy with formocresol and SUAB2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 14 teeth in children who were 7-8 years; Children who were healthy and had the canines that were sound and must be extracted due to orthodontic treatment. Exclusion criteria: Children who were not healthy and did not have any canine tooth that must be extracted due to orthodontic treatment
Age
From 7 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Shahed University Research Center, Kargar St., between Forsat and Nosrat
City
Tehran
Postal code
Approval date
2009-07-01, 1388/04/10
Ethics committee reference number
41/629

Health conditions studied

1

Description of health condition studied
Pulp of primary teeth
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Inflammation- Fibrosis- Necrosis- Internal resorption-
Timepoint
2 months after intervention
Method of measurement
Horsted etal scale

Secondary outcomes

1

Description
Dentinal bridge formation
Timepoint
2 months
Method of measurement
Horsted etal

Intervention groups

1

Description
Pulpotomy with formocresol group: formocresol 1.5, DENTSPLY/a french company, 5 minutes, 1 time
Category
Treatment - Drugs

2

Description
Pulpotomy with SUAB2 group: herbal agent, 5 minutes, 1 time
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
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- Shahed University
Full name of responsible person
Dr Rezvani
Street address
Kargar St., Brtween Forsat and Nosrat
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- Shahed University
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
Dental School Research Center, Shahed university
Full name of responsible person
Mr Vafanoosh
Position
Master of Science
Other areas of specialty/work
Street address
Kargar St., Between Forsat and Nosrat,
City
Tehran
Postal code
Phone
+98 21 6641 9664
Fax
Email
sdntrc@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dept of Operatiove Dentistry, Dental School, Shahed University
Full name of responsible person
Dr Rezvani
Position
Head of Center- Assistant Professor
Other areas of specialty/work
Street address
No 71, Italia St., Vesal Ave
City
Tehran
Postal code
Phone
+98 21 8895 6227
Fax
Email
mbrezvani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental School Research Center, Shahed university
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6641 9664
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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