Protocol summary

Summary
Objective : The aim of this experimental study is to evaluate the pulpal response to electrical pulp tester (EPT)before and after pulpotomy. Design: 60 molar and premolar teeth with irreversible pulpitis referred to the endodontic department of shahid sadoughi university of medical sciences and aged between20 to 60 yrs, are included in this survey. Setting and conduct: Before anesthesia ,teeth are tested with EPT and the responses are recorded. Major Inclusion and Exclusion criteria: Inclusion criteria: molar or premolar teeth; age between 20 to 60 yrs; absence of systemic diseases; lack of analgesic consumption 48h before the tests; history of irreversible pulpitis and spontaneous pain; lack of tenderness to percussion; lack of any other accomplished vitality tests; presence of coronal pulp and absence of excessive tooth destruction; normal apex Exclusion criteria: Moderate to severe periodontitis; non restorable teeth; lack of bleeding after access cavity preparation; systemic disease; coronal leakage; consumption of narcotic drugs; consumption of analgesics Intervention: Emergency pulpotomy treatment are accomplished. 2 to 5 days after pulpotomy, the responses to EPT are recorded again and root canal treatment was completed. Main outcome measures variables: Tooth response to the electrical pulp tester

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031821507N1
Registration date: 2015-05-26, 1394/03/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-26, 1394/03/05
Registrant information
Name
Maryam Kazemipoor
Name of organization / entity
Dental school
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
m.kazemipoor@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Yazd
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the impact of pulpotomy treatment on the response to electrical pulp tester in tooth with irreversible pulpitis
Public title
Evaluation of tooth neurons' response to electrical pulp tester before and after pulpotomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: molar or premolar teeth; age between 20 to 60 yrs; absence of systemic diseases; lack of analgesic consumption 48h before the tests; history of irreversible pulpitis and spontaneous pain; lack of tenderness to percussion; lack of any other accomplished vitality tests; presence of coronal pulp and absence of excessive tooth destruction; normal apex Exclusion criteria: Moderate to severe periodontitis; non restorable teeth; lack of bleeding after access cavity preparation; systemic disease; coronal leakage; consumption of narcotic drugs; consumption of analgesics
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
ٍEthics committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Sadoughi Blv, Shahid Sadoughi University of Medical Science,Yazd
City
Yazd
Postal code
Approval date
2014-07-13, 1393/04/22
Ethics committee reference number
پ/17/1/77713

Health conditions studied

1

Description of health condition studied
Tooth with irreversible pulpitis
ICD-10 code
k04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Response to EPT
Timepoint
2 to 5 days
Method of measurement
EPT apparatus

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
In the first session after EPT readings pulpotomy treatment are accomplished and in the second session after EPT readings root canal treatment were completed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school, Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Maryam Kazemipoor
Street address
Dental school, Dahe Fajr Boulevard, Emam Street, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For reaserch,Shahid Sadoughi University of Medical Scieces
Full name of responsible person
Mrs Mahdieh Khezri
Street address
Dental school, Dahe Fajr Blv, Emam str, Yazd
City
Yazd
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For reaserch,Shahid Sadoughi University of Medical Scieces
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 Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Maryam Kazemipoor
Position
Assisstant professor
Other areas of specialty/work
Street address
Dental school, Dahe Fajr Boulevard, Emam Street, Yazd
City
Yazd
Postal code
Phone
+98 35 3822 9076
Fax
Email
dr.kazemipoor@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid University of Medical Sciences
Full name of responsible person
Maryam Kazemipoor
Position
Assisstant professor
Other areas of specialty/work
Street address
Dental school, Dahe Fajr Boulevard, Emam Street, Yazd
City
Yazd
Postal code
Phone
+98 35 3822 9076
Fax
Email
dr.kazemipoor@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Saman Mahmoodi
Position
Graduate student of dentistry
Other areas of specialty/work
Street address
Dental school, Dahe Fajr Boulevard, Emam Street, Yazd
City
Yazd
Postal code
Phone
00
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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