In this study, we are going to compare the clinical and radiographic outcomes of apexogenesis treatment with MTA and NEC. 40 young patients with deep caries or traumatic exposure on immature permanent teeth will be entered the study. These teeth must have vital pulps with no clinical or radiographic signs of necrosis or infection. Subjects will be randomly divided to MTA and NEC groups. Clinical and radiographic follow ups will be done at 3, 6 and 12 months in order to evaluate the clinical outcomes of treatment and the quality of root development.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805242345N1
Registration date:2009-10-12, 1388/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-12, 1388/07/20
Registrant information
Name
Ali Nosrat
Name of organization / entity
Department of Endodontics, Faculty of Dentistry, Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0031
Email address
alinosrat@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences, Endodontic Research Centre, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2009-08-01, 1388/05/10
Expected recruitment end date
2009-10-01, 1388/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of outcome of apexogenesis treatment with mineral trioxide aggregate and new endodontic cement ( in-vivo study)
Public title
Apexogenesis with mineral trioxide aggregate or new endodontic cement.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: open apex teeth with caries exposure or traumatic exposure of the pulp
Exclusion criteria: teeth with sign and symptoms of infection, periapical radiolucency, or sinus tract
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Rafsanjan
City
Rafsanjan
Postal code
Approval date
2009-05-18, 1388/02/28
Ethics committee reference number
345
Health conditions studied
1
Description of health condition studied
Pulpitis in open apex tooth
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Radiographic success of apexogenesis treatment
Timepoint
3, 6, 12 months after intervention
Method of measurement
Expert opinion
Secondary outcomes
1
Description
Clinical success
Timepoint
1 day, 3, 6 and 12 months after intervention
Method of measurement
clinical examination
Intervention groups
1
Description
Apexogenesis with NEC
Category
Treatment - Other
2
Description
Apexogenesis with MTA
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan University of Medical Sciences, Endodontic Research Centre, Shahid Beheshti University of
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences, Iranian Center for Endodontic Research (Shahid Beheshti Un
Full name of responsible person
Ali Nosrat
Street address
Rafsanjan University of Medical Sciences, Dental School
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences, Iranian Center for Endodontic Research (Shahid Beheshti Un
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nosrat
Position
Assistant prof./DDS,MS.
Other areas of specialty/work
Street address
Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 39 1822 0003
Fax
Email
ansrt2@yahoo.com / alinosrat@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Center for endodontic Research
Full name of responsible person
Saeed Asgary
Position
Prof. of Endodontics/ DDS, MS
Other areas of specialty/work
Street address
Iranian Center for endodontic Research
City
Tehran
Postal code
Phone
+98 22413897
Fax
Email
saasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)