Protocol summary

Summary
In this randomized clinical trials 180 first permanent molars in patients that need to orthodontic band are chosen.The patients must have at least 2 first permanent molars and the teeth must be lack of caries and white spot(ws) lesion.The teeth are examined for caries and presence of WS lesions by visual inspection and also by using DIAGNOdent in 3 point at buccal and lingual side and data are recorded in information sheet.The teeth are cleaned , isolate and dry then orthodontic band are cemented to the teeth using GC Gold Label or GC Fuji Plus GI cements. Samples were divided into 3 groups and bands are removed after 6 months in group 1, 9 months in group 2 and 12 months in group 3. The teeth are then examined for caries and presence of WS lesions by visual inspection and by using DIAGNOdent.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406141882N4
Registration date: 2014-07-04, 1393/04/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Masoud Fallahinejad Ghajari
Name of organization / entity
Facualty of Dentistry, Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
masfalnegh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Total cost of the project is paid by the Dental Research Center, Institute of Dental Sciences، Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2013-01-04, 1391/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of White Spot Lesions around Orthodontic Bands on First Permanent Molars after use of Two Glass Ionomer Cements
Public title
White Spot Lesions Incidence around Orthodontic Bands
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: At least 2 permanent first molars; No whit spot lesion or similar lesions Exclusion Criteria: Presence of Crack and fracture; Presence of caries and white spot
Age
From 6 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Dental Research Center, Research Institute of Dental sciences, Shahid Beheshti University of Medical
Street address
Shahid Beheshti Dental School, Daneshjoo Bulv., Evin
City
Tehran
Postal code
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
جلسه 17

Health conditions studied

1

Description of health condition studied
White spot lesion
ICD-10 code
K02.0
ICD-10 code description
[Caries limited to enamel White spot lesions [initial caries]

Primary outcomes

1

Description
White spot lesio
Timepoint
Befor intervention, 6,9 and 12 months
Method of measurement
Observation and DIAGNOdent unit

Secondary outcomes

1

Description
White spot lesion
Timepoint
6, 9 and 12 months
Method of measurement
Observation and DIAGNOdent unit

Intervention groups

1

Description
Intervention group: GC Gold Label cement Controlled group: GC Fuji Plus cement
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Research Center, Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Street address
Dental school, Daneshjoo Blvd., Evin
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dental Research Center,Research Institute of Dental Siences, Shahid Beheshti University of medical S
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Street address
Dental school, Daneshjoo Blvd., Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center,Research Institute of Dental Siences, Shahid Beheshti University of medical S
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
Dental Research Center, Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr,Azam Naji Rad
Position
Pedodontist
Other areas of specialty/work
Street address
Shahid Beheshti Dental School, Daneshjoo Blvd., Evin
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
Email
dr.anajirad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Research Center, Institute Research Dental Sciences
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Position
Pedodontist/Associated Professor
Other areas of specialty/work
Street address
Shahid Beheshti Dental School, Daneshjoo Blvd., Evin
City
Tehran
Postal code
Phone
+98 21 2240 3080
Fax
Email
masoudfallah36@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental Research Center, Institute of Dental Sciences, Shahi Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Position
Pedodontist/Associate Professor
Other areas of specialty/work
Street address
Shahid Beheshti Dental school, Daneshjoo Blvd., Evin
City
Tehran
Postal code
Phone
+98 21 2240 3080
Fax
Email
masoudfallah36@yahoo.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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