Effect of depotphoresis on bacterial reduction and post treatment pain and healing of priapical lesion
Design
Randomised. parallel group trial with blinded outcom assessment
Settings and conduct
Zahedan dentistry univercity
patient with necros tooth in maxilla and mandible and priapical lesion
main investigator is blind
Participants/Inclusion and exclusion criteria
Patient with necros tooth with priapical lesion
sign consent form
without systemic disease
Intervention groups
1-Depotphoresi
2-Laser
3-Control
Main outcome variables
Pain; healing of preapical; clouny count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180718040517N1
Registration date:2019-01-10, 1397/10/20
Registration timing:registered_while_recruiting
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Maryam Dalaeimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 4323
Email address
maryam.dalaei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Dephotphoresis on Bacterial Reduction and Post treatment Pain and Healing of Preapical lesion: A Randomized Clinical Trial
Public title
Effect of Dephotphoresis on Healing of Dental Lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient that have necrose teeth in maxilla and mandible with preapical lesions
Patient with consentform
without any systemic disease
without extensive crown decay
people with age of betwean 12 and 60 years old
Randomization by use of computer software and by random block with size of 3 and 6 and attribution proportion 1:1:1in two intervention group and control group are performance. for allocation concealment kind of intervention are written in paper inside pocket numbered .pockets open by investigator respecttively and intervention permormance
Blinding (investigator's opinion)
Single blinded
Blinding description
Personel of laboratory
Method of study explain fot patient and explain they may put in one of study group and take them inform consent.
fot this during treatmen with depotphoresis laser tip enter to patient mouth and vice versa
Placebo
Not used
Assignment
Parallel
Other design features
use of depotphoresis
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of zahedan medical university
Street address
Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.ZAUMS.REC.1397.278
Health conditions studied
1
Description of health condition studied
Diseases of oral cavity, salivary glands and jaws
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis
Primary outcomes
1
Description
Groupes that participate in study
Timepoint
6 h.12h.24h.48.72h after first treatment
Method of measurement
Questionnaire
2
Description
Healing of lesion
Timepoint
6 months.12 months
Method of measurement
Clinical and radiographic evaluation
3
Description
Colony count
Timepoint
1.5 years
Method of measurement
PCR
Secondary outcomes
empty
Intervention groups
1
Description
Depotphoresis(Depotphoresis equipment Humanchemie GmbH Alfeld Germany):the root canal is filled with coper calcium solution( one section copral with 9 section calcium hydroxide) and then a weak electrical current(0.8 to 1.5ma) is sent through a fine probe. 3 time with 5 minute interval.electrical current need in one session.
Category
Treatment - Devices
2
Description
Laser diod with 200 um diameter and power of 2 W are used.laser activated and fiber guided in an apical direction to the coronal area with rotary movement and in contact with the root canal wall.the procedure was repeated 3 time with interval of 2 minutes.
Category
Treatment - Devices
3
Description
Control group with conventional endodontic treatment
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry university
Full name of responsible person
Maryam Dalaei Moghadam
Street address
Tirandazi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Fax
+98 54 3344 1824
Email
Maryam.Dalaei@yahoo.com
Web page address
Http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dalaei Moghadam
Street address
Zahedan Medical University، Dr Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1820
Fax
+98 54 3344 1820
Email
Maryam.Dalaei@yahoo.com
Web page address
Https://msrc.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
The Research Assistance of Zahedan Medical University
Full name of responsible person
Eshagh Ali Saberi
Street address
Medical University, Dr Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Fax
+98 54 3344 1824
Email
E.saberi@yahoo.com
Web page address
Https://msrc.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Research Assistance of Zahedan Medical University
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dalaei Moghadam
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tirandazi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816874978
Phone
+98 912 040 7133
Fax
+98 54 3344 1824
Email
Maryam.Dalaei@yahoo.com
Web page address
Https://msrc.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dalaei Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tirandazi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816874978
Phone
+98 912 040 7133
Fax
+98 54 3344 1824
Email
Maryam.Dalaei@yahoo.com
Web page address
Https://zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Dalaei Moghadam
Position
Resideni
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tirandazi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816874978
Phone
+98 912 040 7133
Fax
+98 54 3344 1824
Email
Maryam.Dalaei@yahoo.com
Web page address
Https://msrc.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effect of depotphoresis on healing of periapical lesion
When the data will become available and for how long
One year after publicasion
To whom data/document is available
Person who are practitioner in university
Under which criteria data/document could be used
-
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document