The aim of this study is to assess color stability during 6 months between white spot lesions and sound adjacent enamel areas after resin infiltration. This is a double-blind, non randomized trial. Patients with 57 anterior teeth who have white spot lesions- because of post orthodontic treatment or hypomineralization- are selected. The patients have 14 up 21 year-old. These teeth meet the following criteria: inactive lesions with smooth, shiny surface. Only the teeth longer than 3 months elapsed after debonding are selected to exclude those in active lesion state. Patients give informed consent before the start of the trial. During the trial, participants are given the same type of toothbrushes (Oral-B Classic Care, India) and dentifrices (Oral-B) for oral hygiene home care. The content of mineralization of lesions and its extension are determined using VistaCam ix camera. For the maximum protection of patients during treatment, the patients are made to wear the eye glasses, and rubber dam. The tooth surface is cleaned with a rubber cup and prophylaxis paste. All teeth are treated with icon resin infiltration according to manufacturer's recommendation. Standardized digital photographs are taken before, immediately after, and 1 month, 3 and 6 months after infiltration.. The difference ( ∆E ) in color between the sound enamel and lesions at each time is calculated with the measured CIE L*a*b* values. A ∆E>3.7 is considered a clinical indicator for color change
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112720116N1
Registration date:2015-04-23, 1394/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-23, 1394/02/03
Registrant information
Name
Atoosa Talebi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2301
Email address
talebia911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-20, 1394/01/31
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of resin infiltration in color stability of white spot lesions in labial surface of teeth; a clinical trial
Public title
Effect of resin infiltratin in color stability of white spot lesions in teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 14 up 21 year-old; having inactive labial white spot lesions with smooth and shiny surface; the teeth longer than 3 months elapsed after debonding( if it is because of orthodontic treatment).
Exclusion criteria: active lesions; cavited lesions; primary teeth; filled teeth; 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:
57
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Ghoraishy Building, University st.
City
Mashhad
Postal code
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
930116
Health conditions studied
1
Description of health condition studied
White Spot Lesions in Teeth
ICD-10 code
K02.0
ICD-10 code description
White Spot Lesions
Primary outcomes
1
Description
Color stability
Timepoint
before treatment, baseline, one month, three months, six months after treatment
Method of measurement
Spectrophotometry, digital photography.
Secondary outcomes
1
Description
Color change
Timepoint
before treatment, baseline,one month, three months, six months after intervention
Method of measurement
Spectrophotometry, digital photography
Intervention groups
1
Description
Intervention Group: white spot lesion in tooth
Category
Treatment - Drugs
2
Description
Control Group:the other point except white spot lesion in the same tooth
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry of Mashhad
Full name of responsible person
Dr. Mohammad Javad Moghaddas
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoraishi Building, University st.
City
Mashhad
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
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
School of Dentistry of Mashhad
Full name of responsible person
Mohammad Javad Moghaddas
Position
Associate Professor of Restorative Dentistry
Other areas of specialty/work
Street address
Restorative Department, School of Dentistry, Vakil Abad blvd., Azadi Sq.
City
Mashhad
Postal code
91735
Phone
+98 51 3883 2301
Fax
Email
moghaddasmj@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry of Mashhad
Full name of responsible person
Mohammad Javad Moghaddas
Position
Associate Professor of Restorative Dentistry
Other areas of specialty/work
Street address
Restorative Department, School of Dentistry, Vakil Abad blvd., Azadi Sq.
City
Mashhad
Postal code
91735
Phone
+98 51 3883 2301
Fax
Email
moghaddasmj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry of Mashhad
Full name of responsible person
Mohammad Javad Moghaddas
Position
Associate Professor of Restorative Dentistry
Other areas of specialty/work
Street address
Restorative Department, School of Dentistry, Vakil Abad blvd., Azadi Sq.
City
Mashhad
Postal code
91735
Phone
+98 51 3883 2301
Fax
Email
moghaddasmj@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)