Protocol summary

Study aim
The aim of the study was to evaluate the color stability of white spot treated lesions with resin infiltration technique and its relation with their size.
Design
The clinical trial, not blind, single
Settings and conduct
The Restorative Department of Mashhad Dental School Patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age range of participants was between 14 to 21 years Inactive, smooth and glossy labially lesions lesions in orthodontic patients who removed their brackets for 3 months Exclusion criteria: Active and cavitated lesions, Deciduous teeth, Restored teeth adjacent to white spots, Poor oral hygiene
Intervention groups
Application of resin infiltration technique on white spot lesions
Main outcome variables
The improvement of white spot lesions appearance also its durability, and decreaing their size followed by Resin Infiltration application

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180624040223N1
Registration date: 2018-07-18, 1397/04/27
Registration timing: retrospective

Last update: 2018-07-18, 1397/04/27
Update count: 0
Registration date
2018-07-18, 1397/04/27
Registrant information
Name
Roya Amiri Daluyi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 2020
Email address
Amiridr931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
2015-10-07, 1394/07/15
Actual recruitment end date
2016-04-08, 1395/01/20
Trial completion date
empty
Scientific title
Evaluation of Durability of Esthetic Improvement of White Spot Lesions by Applying Resin Infiltration Technique
Public title
Effect of Resin Infiltration Technique on White Spot Lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 14 to 21 years In active , smooth and glossy lesions in labial surface Lesions in orthodontic patients who removed their brackets for 3 months
Exclusion criteria:
Active and cavitated lesions Deciduous teeth Restored teeth adjacent to white spot lesions Poor oral hygiene
Age
From 14 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Actual sample size reached: 16
Randomization (investigator's opinion)
Not randomized
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
The Research Ethics Committee Of Mashhad Dental School
Street address
Vakil-Abad Blv, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
930116

Health conditions studied

1

Description of health condition studied
People with labial white spot lesions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Color variation of lesions after treatment and in follow up sessions with the initial color
Timepoint
Before the intervention, immediately after the intervention, 1,3 and 6 months after intervention
Method of measurement
Spectrophotometer and Digital Camera

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Resin Infitration (ICON) , DMG Company, Germany. 1 time application
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Restorative Department of Mashhad Dental School
Full name of responsible person
Alireza Boruzi Niyat
Street address
Vakil-Abad Blv, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
amiridr931@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakil-Abad Blv, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
amiridr931@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
Full name of responsible person
Roya Amiri Daluyi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil-Abad Blv, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3765 2020
Email
amiridr931@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roya Amiri Daluyi
Position
RESIDENT
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil-Abad Boulevard,Dental School, Mashhad University of Medical Sciences ,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3765 2020
Fax
Email
amiridr931@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roya Amiri Daluyi
Position
RESIDENT
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil-Abad Boulevard,Dental School, Mashhad University of Medical Sciences ,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3765 2020
Fax
Email
roya_amiri65@yahoo.com

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
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