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A comparative study of the effect of pulpotomized primary molars using CEM cement, Formocresol , MTA and Laser

Protocol summary

Summary
Pulpotomy is one of the most common treatments for deciduice teeth used by dentists particularly pediatrists . This research aims to compare CEM ( introduced recently by Dr Asgary and colleagues) with other materials and techniques such as MTA , formocresol and laser use in pulpotomy of deciduice teeth. Nowadays , the most commonly used material for deciduice teeth pulpotomy treatment is formocresol .further investigations are needed on laser therapy of deciduice teeth .Some researches indicate relative superiority of CEM over MTA . in this randomized clinical trial study , 120 pair of first and second deciduice molar teeth who prescribed pulpotomy treatment of Patients aged 5-8 years old are divided into four test groups. In group one, a cotton ball soaked in formocresol is placed on canal orifices for 5 minutes , and after its color change ,pulp chamber is gently filled by 2 mm of reinforced ZOE . In group two and three, pulp chamber is filled gently by 2mm MTA and CEM, respectively .In these 3 groups ,SDI amalgam is used as tooth restoration . In group 4 ,laser is radiated into canal orifice using a specialized handpiece After clinical examinations and taking radiography in the same session ,patients will be reevaluated clinically and radiographically after 6 and 12 months.Results of clinical evaluations and priapical radiographies of the first session , 6th and 12th months will be recorded and compared.

General information

Acronym
vpt
IRCT registration information
IRCT registration number: IRCT138706241191N2
Registration date: 2008-10-07, 1387/07/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2008-10-07, 1387/07/16
Registrant information
Name
Saeed Asgary
Name of organization / entity
Iranian Center for Endodontic Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 3897
Email address
sasgari@icdr.ac.ir
Recruitment status
Recruitment complete
Funding source
iran center of dental research and iran center of endodontics research
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-05-20, 1388/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of pulpotomized primary molars using CEM cement, Formocresol , MTA and Laser
Public title
vital pulp therapy in primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with good cooperation and no systemic disorder , developmental deficiencies , mental retardation nor physical disability which hampers their cooperation and no medication therapy were selected for this study. And they select based on following clinical and radiographic criteria: Clinical criteria: 1-lack of spontaneously pain 2- lack of obvious mobility 3- lack of sensitivity to percussion 4-lack of swelling and fistula and no sign of necrosis and abscess or redness of gingival adjacent to apex area 5-lack of extensive irrepairable coronal decay 6- lack of regional lymphodenopathy 7- lack of periodontal pocket Radiographic criteria: 1-extention of decay to pulp region without any of above clinical signs and symptoms 2- lack of internal and external resorption 3-lack of calcific degeneresence pulp or pulp stone 4-lack of periapical or furcation radiolucency.
Age
From 5 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Iran Center for Dental Research
Street address
5th floor , shahid beheshti dental school, Evin
City
Tehran
Postal code
19839613113
Approval date
2008-06-10, 1387/03/21
Ethics committee reference number
8719

Health conditions studied

1

Description of health condition studied
vital pulp therapy of primary molars
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
presence of pain
Timepoint
next day
Method of measurement
Yes or No

Secondary outcomes

1

Description
radiographical success rate of treatment
Timepoint
first secion,6th and 12th month
Method of measurement
priapical radiography

Intervention groups

1

Description
pulpotomy with MTA(mineral trioxide aggregate)
Category
empty

2

Description
pulpotomy with CEM(new endodontic cement)
Category
empty

3

Description
pulpotomy with formocresol
Category
empty

4

Description
pulpotomy with laser
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
dental school of shahid beheshti university
Full name of responsible person
Dr.Beheshteh Malek afzali
Street address
shahid beheshti dental school, Evin ,Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
dental school of shahed university
Full name of responsible person
Dr majid mehran
Street address
shahed dental shool,Italia st. Keshavarz Blvd,Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
dental school of mashhad university
Full name of responsible person
Dr alireza sarraf
Street address
dental school of mashhad university,across the melat park,Vakil abaad Blvd,Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
iran center of endodontics research center
Full name of responsible person
Dr.saeed asgary
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iran center of endodontics research center
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
iran center of dental research
Full name of responsible person
Dr.seyyed mohammad reza safavi
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
iran center of dental research
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
dental school of shahed university
Full name of responsible person
Dr majid mehran
Street address
pediatrics department,dental school of shahed university,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
dental school of shahed university
Proportion provided by this source
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

4

Sponsor
Name of organization / entity
dental school of mashhad university
Full name of responsible person
Dr alireza sarraf
Street address
pediatrics department,dental school of mashhad medical university,mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
dental school of mashhad university
Proportion provided by this source
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
endodontics research center
Full name of responsible person
Mohammad Jafar Eghbal
Position
wise president(research)/endodontist
Other areas of specialty/work
Street address
iran center of endodontics research center, dental school of shahid beheshti university,Evin,tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98-21-22413897
Fax
+98-21-22427753
Email
mje782002@yahoo.com
Web page address
www.icdr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
iran center of endodontics research center
Full name of responsible person
Saeed Asgary
Position
president/endodontist
Other areas of specialty/work
Street address
iran center of endodontics research center, dental school of shahid beheshti university,Evin,tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
+98 21 2242 7753
Email
sasgary@yahoo.com
Web page address
www.icdr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
iran center of dental research
Full name of responsible person
Bahareh Shadman
Position
dentist/DDS
Other areas of specialty/work
Street address
5th floor , shahid beheshti dental school, Evin ,Tehran
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
+98 21 2242 7753
Email
baharshadman@gmail.com, bahshad@yahoo.com
Web page address
www.icdr.ac.ir

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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