A clinical trial to compare the effectiveness of photodynamic therapy with light and laser on streptococcus mutans in patients undergoing fixed orthodontic treatment
To compare the effectiveness of photodynamic therapy with light and laser on streptococcus mutans in patients undergoing fixed orthodontic treatment
Design
A randomized, clinical trial based on random number table
Settings and conduct
Patients undergoing fixed orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, in a not blind study, are aware of the type of Streptococcus mutans treatment.
Participants/Inclusion and exclusion criteria
Patients undergoing fixed orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry
Intervention groups
Intervention Group I will receive chlorine-based photodynamic therapy with wavelength of 660 nm and red laser diodes power of 200 µ. Intervention Group II will be subjected to toluidine blue-mediated photodynamic therapy with wavelength of 480 nm and light blue LED power of 2000-4000 mw/cm. Intervention Group III will receive photodynamic therapy using Emondo as photocatalytic material with wavelength of 810 nm and laser power of 200 µ. The three groups receive the interventions for 45 second once a week for 4 weeks. The control group does not receive photodynamic therapy.
Main outcome variables
Evaluation and comparison of the effectiveness of photodynamic therapy on the Streptococcus mutans count in 4 groups, which are sampled by sterile swabs from 6 anterior teeth and measured by microbial counting before and 4 weeks after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037270N1
Registration date:2017-12-09, 1396/09/18
Registration timing:prospective
Last update:2017-12-09, 1396/09/18
Update count:0
Registration date
2017-12-09, 1396/09/18
Registrant information
Name
Elnaz Hajhemati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 5886
Email address
razmavarm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-12-31, 1396/10/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of photodynamic therapy with light and laser on streptococcus mutans in patients undergoing fixed orthodontic treatment
Public title
The effectiveness of photodynamic therapy on streptococcus mutans
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing fixed orthodontic treatment
Healthy teeth condition
No oral lesions
Exclusion criteria:
Mass of gum
Severe caries
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized based on random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
In a single-blind study, the patients are not aware of the type of Streptococcus mutans treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2015-05-15, 1394/02/25
Ethics committee reference number
IR.MUMS.SD.REC.1394.146
Health conditions studied
1
Description of health condition studied
orthodontic
ICD-10 code
Z46.5
ICD-10 code description
Fitting and adjustment of ileostomy and other intestinal appliances
Primary outcomes
1
Description
The Streptococcus mutans count
Timepoint
Before and 4 weeks after the intervention
Method of measurement
Microbial counting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group I: Who will receive chlorine-based photodynamic therapy with wavelength of 660 nm and red laser diodes power of 200 µ for 45 second once a week for 4 weeks.
Category
Prevention
2
Description
Intervention Group II: Who will be receive toluidine blue-mediated photodynamic therapy with wavelength of 480 nm and light blue LED power of 2000-4000 mw/cm 45 second once a week for 4 weeks.
Category
Prevention
3
Description
Intervention Group III: Who will receive photodynamic therapy using Emondo as photocatalytic material with wavelength of 810 nm and laser power of 200 µ for 45 second once a week for 4 weeks.
Category
Prevention
4
Description
Control group: Who does not receive photodynamic therapy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Elnaze Hajhemati
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
elnazhematy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
۳۴۵ - ۹۱۳۷۵
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad Faculty of Dentistry
Full name of responsible person
Elnaze Hajhemati
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
Email
elnazhematy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Elnaze Hajhemati
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
Email
elnazhematy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Elnaze Hajhemati
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
Email
elnazhematy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Elnaz Hajhemati provides the analysis code to the applicants via email: elnazhematy@yahoo.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.