Protocol summary

Summary
Introduction and background: Pulpotomy is the most common pulp treatment in primary teeth. Final restoration of pulpotomized primary molar can have an effect on the failure of the endodontic treatment. The aim of this study was to compare the success rate of formocresol pulpotomy in primary molars restored with stainless steel crowns with those restored with amalgam. Design: this study was done as randomized clinical trial. Setting and conduct: 110 primary molars that met inclusion criteria pulpotomized with a conventional technique were randomly divided into 2 groups. In the amalgam group teeth were restored with amalgam and in SCC group teeth were restored with Stainless Steel Crown. Participants: 110 primary molars in children who were 4-7 years old. Inclusion criteria: the children who were healthy and did not have any contraindication for pulpotomy and did not have clinical and radiographic signs of radicular inflammation. Exclusion criteria: the children who were not healthy and those for whom pulpotomy was contraindicated and had clinical and radiographic signs of radicular inflammation. Intervention: After pulpotomy the teeth in SCC group were restored with SCC ( 3M ESPE U.S.A ), and the teeth in amalgam group were restored with amalgam (Sinalux plus Sh. Dr. Faghihi Dental Co). Clinical and radiographic success was evaluated after 6, 12, and 24 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903023316N5
Registration date: 2011-01-01, 1389/10/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-01-01, 1389/10/11
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
2006-04-22, 1385/02/02
Expected recruitment end date
2008-07-23, 1387/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of stainless steel and amalgam in restoration of pulpotomized primary molars
Public title
Different types of restoration of pulpotomized primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the children who were healthy and did not have any contraindication for pulpotomy and did not have clinical and radiographic signs of radicular inflammation. Exclusion criteria: the children who were not healthy and those for whom pulpotomy was contraindicated and had clinical and radiographic signs of radicular inflammation
Age
From 4 years old to 7 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 110
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 research center - Shahed University
Street address
Research center- between Forsat and Nosrat- Kargar Str
City
Tehran
Postal code
Approval date
2006-04-08, 1385/01/19
Ethics committee reference number
46/2-2054

Health conditions studied

1

Description of health condition studied
Pulpotomized primary molars
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Pain- Swelling- Mobility- Sesitivity to percussion- Internal resorption- External resorption- Furcal radiolucency
Timepoint
6months- 12 months-24months
Method of measurement
Explorer- Mirror- Radiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Teeth restored by stainless steel crown (3M ESPE U.S.A )
Category
Treatment - Devices

2

Description
Control group: Teeth restored by amalgam( Sinalux, Sh Dr Faghihi, Dental Co)
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dept of Pediatric Dentistry- Dental School- Shahed University
Full name of responsible person
Kalantary
Street address
N71- Italia Str- Vesal Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center, Shahed University, Dental School
Full name of responsible person
Dr Mohammad Bagher 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, Shahed University, Dental School
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
MSC
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 21 6641 9664
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 Mohammad Bagher 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 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
Dr Mohammad Bagher 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 21 8895 6227
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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