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Evaluation the effects of diode laser (810nm) on microbial load and temperature changes in surface root and texture Periodontium after Endodontic therapy and root canal therapy

Protocol summary

Summary
The goals of this in vivo research are to evaluate temperature rise in periodontal tissue in buccal and lingual following intra canal irradiation in laser assisted endodontic treatment with 810-nm diode laser and Er, Cr:YSGG and also evaluation of bactericidal effect of 810 nm diode laser in teeth with apical periodontitis. Forty patients will participate in this research, each patient with a single canal tooth. Teeth will sterilize with 810 nm, power 1, 1.2,1.4,1.5,2 W, fiber 200 n m in the continuous mode (CW), radiation time 1sec/2 mm,4 times for each canal from apical to coronal, with circular movement. Temperature of periodontal tissue in 2 sides buccal and lingual and root surface in thirds will record by digital thermometer, body temperature will record exactly in that area of periodontal tissue and tooth before treatment too. In the following 40 patients with anterior or posterior teeth randomly will include in Laser and control group. After access to pulp chamber a file will insert inside the canal to move in the pulp, then canal will irrigate with 0.2 ml sterile saline solution. Canal will dry with 3 sterile paper points. Each paper cone left inside the canal after 30 seconds. These paper cones as first microbial samples will add to 200 BHI broth and will send to microbiology laboratory.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016022926822N1
Registration date: 2016-04-21, 1395/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Elina Aghassi
Name of organization / entity
First private laser clinic in operative, periodontics and endodontics in North of Iran
Country
Iran (Islamic Republic of)
Phone
+98 11 3228 8969
Email address
elina.aghasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-02-22, 1394/12/03
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of diode laser (810nm) on microbial load and temperature changes in surface root and texture Periodontium after Endodontic therapy and root canal therapy
Public title
Effect of laser on tooth tissues and antimicrobial status.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients signed the informed contest to participate in this study Exclusion criteria: Patients with systemic disease
Age
From 18 years old to 60 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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gang Afrooz Ave, Babol, Mazandaran
City
Babol
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
MUBABOL.REC.1394.260

Health conditions studied

1

Description of health condition studied
Patient with tooth root infections
ICD-10 code
k08
ICD-10 code description
Tooth root infection

Primary outcomes

1

Description
Antibacterial status (Microbial)
Timepoint
Before and after study
Method of measurement
Microbial analysis in the laboratory

2

Description
Measurement of temperature change
Timepoint
Before and after study
Method of measurement
Thermometer non-contact, Microlohe NC100

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving laser.
Category
Treatment - Other

2

Description
Placebo group: Receiving mouthwash.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Dr. Elina Aghassi
Street address
Mazandaran, Babol, square Keshvari.
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Elina Aghassi
Street address
Mazandaran, Babol, Square Keshvari.
City
Babol
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Clinic
Full name of responsible person
Dr. Elina Aghassi
Position
Dentist
Other areas of specialty/work
Street address
Mazandaran, Babol, Square Keshvari.
City
Babol
Postal code
-
Phone
+98 11 3228 8969
Fax
-
Email
elina.aghasi@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Clinic
Full name of responsible person
Dr. Elina Aghasi
Position
Dentist
Other areas of specialty/work
Street address
Mazandaran, Babol, Square Keshvari.
City
Babol
Postal code
-
Phone
+98 11 3228 8969
Fax
-
Email
elina.aghasi@gmail.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Clinic
Full name of responsible person
Dr. Elina Aghasi
Position
Dentist
Other areas of specialty/work
Street address
Mazandaran, Babol, Square Keshvari.
City
Babol
Postal code
Phone
+98 11 3228 8969
Fax
-
Email
elina.aghasi@gmail.com
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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