Currently the most common material used in primary molar pulpotomy is ferric sulfate and formocresol. But the usefullness of formocresol has been questionable due to its systemic toxicity. Despite the clinical success of ferric sulfate and formocresol, histological studies, have shown a sever inflammatory response.
An alternative to pulpotomy is sodium hypochlorite that is a good antimicrobial agent without significant irritation to pulp. and sodium hypochlorite, is a hemostating factor, and the most critical factor for clinical success in pulpotomy procedure.
The aim of this study is to compare the clinical and radiographic success rate of ferric sulfate and sodium hypochlorite pulpotomy in primary molars.In the initial evaluation of these teeth, there should be no pulpotomy contraindications . otherwise the patient will be excluded. In this study children 5-8 years old with at least two primary second molars needs pulpotomy, will be studied.This study is a double blind randomized clinical trial. Teeth are pulpotomized and dried with sterile cotton pellets placed in the pulp chamber for 5 minutes. In case of continuous bleeding, tooth is excluded from study. If bleeding stopped, study in two groups continues. Group1:pulpotomy with ferric sulfate 15.5% ,Group2:pulpotomy with 5% sodium hypochlorite, which is placed in the cavity. Then in both groups Zinc Oxide Eugenol is placed as a base and then restore with stainless steel crown. The number of samples examined in this study is 60, 30 in ferrous sulfate group and 30 in sodium hypochlorite group.
The teeth will be assessed for clinical and radiographic success for a period of 6and12 months .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100711028N1
Registration date:2013-05-20, 1392/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-20, 1392/02/30
Registrant information
Name
Zahra Dehghan
Name of organization / entity
Islamic Azad University khorasgan Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1673 3103
Email address
za.dehghan@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University khorasgan Branch
Expected recruitment start date
2013-05-12, 1392/02/22
Expected recruitment end date
2013-06-12, 1392/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of success rate of ferric sulfate and sodium hypochlorite for primary molar teeth pulpotomy in 5-8 years children .
Public title
sodium hypochelorite pulpotomy success in primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children 5-8 years old; presence of at least 2 primary second molars teeth in mandible requiring pulpotomy.
Exclusion criteria:Children over 8 years; Absence of two primary second molars in mandible; pulpotomy contraindications of primary molars including: nocturnal pain; presence of fistulas; abscesses, internal and external root resorption; periapical lucency; furcal lucency; Continous bleeding after removing the pulp and placed dry cotton for 5 minutes;teeth wich will show phisyologic mobility or exfuliated in 6 or 12 months fallow up.
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:
60
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
Islamic Azad University Khorasgan Branch
Street address
University BLVD, Arghavanie, East jey street, Esfahan
City
Esfahan
Postal code
Approval date
2012-11-06, 1391/08/16
Ethics committee reference number
91020909312
Health conditions studied
1
Description of health condition studied
pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Internal resorption
Timepoint
6 months after the intervention, and 12 months after intervention
Method of measurement
radiography
2
Description
dental abscess and fistula
Timepoint
6 months after the intervention, and 12 months after intervention
Method of measurement
clinical examination
3
Description
periapical radiolucency
Timepoint
6 months after the intervention, and 12 months after intervention
Method of measurement
radiography
4
Description
pain
Timepoint
6 months after the intervention, and 12 months after intervention
Method of measurement
clinical examination and questions
Secondary outcomes
1
Description
external resorbtion
Timepoint
Baseline, 6 months after the intervention, and 12 months after intervention
Method of measurement
radiography
2
Description
furcal radiolucency
Timepoint
6 months after the intervention, and 12 months after intervention
Method of measurement
radiography
Intervention groups
1
Description
intervention group: after pulpotomy, sodium hypochlorite is placed into the pulp chamber as the drug for30 second
Category
Treatment - Drugs
2
Description
Control Group: after pulpotomy, ferric sulfate is placed into the pulp chamber as the drug for15 second.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Khorasgan Branch, Dental School,Department of Pediatric Dentisry
Full name of responsible person
Zahra Dehghan
Street address
University BLVD, Arghavanie, East jey street, Esfahan
City
Esfahan
2
Recruitment center
Name of recruitment center
khanevadeh Special Dental Clinic
Full name of responsible person
Zahra Dehghan
Street address
Baharestan Hospital, Sofeh Ave., Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University khorasgan Branch
Full name of responsible person
Zahra Zehghan
Street address
No:27, 8th street, koye sepahan, Esfahan, Iran
City
Esfahan
Grant name
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University khorasgan Branch
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
Islamic Azad University Khorasgan Branch
Full name of responsible person
Zahra Dehghan
Position
Resident of Pediatric Dentisry
Other areas of specialty/work
Street address
No:27, 8th street, Koye sepahan, Esfahan, Iran
City
Esfahan
Postal code
Phone
+98 31 1673 3103
Fax
+98 31 1535 4053
Email
za.dehghan@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Davood Ghasemi
Position
Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
University BLVD, Arghavanie, East jey street, Esfahan
City
Esfahan
Postal code
Phone
+31 15354001
Fax
Email
za.dehghan@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Zahra Dehghan
Position
Resident of Pediatric Dentisry
Other areas of specialty/work
Street address
No:27,8th Street, Koye sepahan, Esfahan, Iran
City
Esfahan
Postal code
Phone
+98 31 1673 3103
Fax
Email
za.dehghan@khuisf.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)