Comparision evaluation of Puls oximetry, Electrical Pulp test and Cold Test for assessing pulp vitality in permanent immature vital teeth, in 8-12 years old children
This study aimed to compare pulse oximetry, electric pulp test and cold test in assessing pulp vitality of immature vital permanent teeth. Study design is observentional. Patients aged 8-12 years old with immature vital maxillary central and lateral incisors are include in the study.Patients should have panoramic radiographs to determine the stage of root development Otherwise are excluded. Additional radiographs will not take. the number of patients is 120 .pulp vitality will assess by puls oximeter, electrical pulp test and cold test. These 3 methods will compare in permanent immature vital teeth. No other intervention takes place and It is just a diagnostic study. Any re-evaluation will not performed at another interval.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022326723N1
Registration date:2016-04-16, 1395/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-16, 1395/01/28
Registrant information
Name
Fatemeh Molaasadolah
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
fm.asadollah@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental school, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision evaluation of Puls oximetry, Electrical Pulp test and Cold Test for assessing pulp vitality in permanent immature vital teeth, in 8-12 years old children
Public title
Comparision evaluation of Puls oximetry, Electrical Pulp test and Cold Test for assessing pulp vitality in permanent immature vital teeth
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: patients without systemic disease with healthy, immature permanent maxillary central and lateral teeth and a crown of clinically healthy without caries, fracture, discoloration and restoration; no history of trauma in the head and face and radiographs to determine root developmental stage
Exclusion criteria: developmental and structural defects in teeth to the presence of symptoms of pain and inflammation and periodontal disease.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of medical Sciences
Street address
journal of dental school, 4th floor , dental school, Shahid Beheshti University of medical Sciences , Daneshjoo Bvld , Evin , shahid Chamran highway
City
Tehran
Postal code
1983963113
Approval date
2015-12-28, 1394/10/07
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.107
Health conditions studied
1
Description of health condition studied
Pulp vitality of immature teeth
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
Cold test
Timepoint
Before intervention
Method of measurement
Cold spray
2
Description
Electrical pulp test
Timepoint
Before intervention
Method of measurement
EPT device
Secondary outcomes
empty
Intervention groups
1
Description
pulp vitality
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Foroogh Akbari
Street address
Pediatric Department, Dental School, Shahid Beheshti University of medical Sciences, Daneshjoo Bvld., Evin, Shahid Chamran highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrokh Amini
Street address
4th floor, Dental School, Shahid Beheshti University of medical Sciences, Daneshjoo Bvld., Evin, Shahid Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Foroogh Akbari
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental School, Shahid Beheshti University of medical Sciences, Daneshjoo Bvld., Evin, Shahid Chamran highway
City
Tehran
Postal code
Phone
+98 21 8827 5008
Fax
Email
akbariforooghdds@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Mollaasadolah
Position
Asistant professor in pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental School, Shahid Beheshti University of medical Sciences, Daneshjoo Bvld., Evin, Shahid Chamran highway
City
Tehran
Postal code
Phone
+98 21 2990 2304
Fax
Email
fma.allah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Foroogh Akbari
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric Department, Dental School, Shahid Beheshti University of medical Sciences, Daneshjoo Bvld., Evin, Shahid Chamran highway
City
tehran
Postal code
1983963113
Phone
+98 21 8827 5008
Fax
Email
akbariforooghdds@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)