Effect of fluoride varnish, mouthwash, and Diode laser versus no intervention on enamel white spot lesions in orthodontic patients: a randomized clinical trial
To assess the effect of fluoride varnish, mouthwash, and Diode laser versus no intervention on enamel white spot lesions in orthodontic patients
Design
This a randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible orthodontic patients who will refer to School of Dentistry during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Having bracket
Enamel white spot lesions
Exclusion criteria:
Wide dental caries
Inappropriate oral hygiene
Systemic diseases
Smoking
A history of chemotherapy or radiotherapy
A history of fluoride therapy in the last 3 months
Pregnancy
Intervention groups
Intervention group 1: Covering tooth surface with fluoride varnish for 4 min and then Diode laser irradiation 980 nm, 1 w, 600 µm, once
Intervention group 2: Covering tooth surface with fluoride varnish for 4 min once
Intervention group 3: Using fluoride mouthwash 0.2% for 30 seconds once
Control group: Just routine dental care without any intervention
Main outcome variables
Primary outcome: Assessing the enamel white spot lesions before intervention and then every month for three months through physical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N219
Registration date:2018-05-05, 1397/02/15
Registration timing:registered_while_recruiting
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2018-07-09, 1397/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fluoride varnish, mouthwash, and Diode laser versus no intervention on enamel white spot lesions in orthodontic patients: a randomized clinical trial
Public title
Effect of fluoride varnish, mouthwash, and Diode laser versus no intervention on enamel white spot lesions in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Having bracket
Enamel white spot lesions
Exclusion criteria:
Wide dental caries
Inappropriate oral hygiene
Systemic diseases
Smoking
A history of chemotherapy or radiotherapy
A history of fluoride therapy in the last 3 months
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.UMSHA.REC.1396.875
Health conditions studied
1
Description of health condition studied
Orthodontic patients
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Assessing the enamel white spot lesions
Timepoint
Before intervention and then every month for three months
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Covering tooth surface with fluoride varnish for 4 min and then Diode laser irradiation 980 nm, 1 w, 600 µm, once
Category
Treatment - Surgery
2
Description
Intervention group 2: Covering tooth surface with fluoride varnish for 4 min once
Category
Treatment - Drugs
3
Description
Intervention group 3: Using fluoride mouthwash 0.2% for 30 seconds once
Category
Treatment - Drugs
4
Description
Control group: Just routine dental care without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Sara Ebrahimi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sara Ebrahimi
Position
Resident of Orthodontic
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara_ebrahimi64@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Sara Alijani
Position
Orthodontist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
alijani_sara@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available