Protocol summary

Summary
Objectives:Bioactive glass is used as an antibacterial agent. This study aimed to assess the effect of addition of BAG to glass ionomer cement on accumulation of Streptococcus mutans and Lactobacilli around orthodontic bands. Designing: This clinical trial was conducted on 10 patients requiring orthodontic treatment with lingual arch and molar bands. Method: In five patients, Fuji II SC GIC was used for cementation of the right and Fuji II SC containing 30wt% BAG was used for cementation of the left molar band. In the remaining five patients, Fuji II LC was used for cementation of the left and Fuji II SC containing 30wt% BAG was used for cementation of the right molar band. Inclusion criteria patient consent for participation in this study; good oral hygiene; absence of active caries or periodontal disease; no mouth breathing;absence of cleft lip or palate; absence of conditions affecting oral microbial flora; absence of conditions affecting tooth brushing and no use of chlorhexidine mouthwash or antibiotics within three weeks prior to this study or during the course of study. Exclusion criteria. Wash out of cement and loosening of appliances Main outcomes:Formation of S. mutans and Lactobacillus colonies in the culture medium was assessed and number of colonies was counted using a colony counter

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061134451N1
Registration date: 2017-07-08, 1396/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Maryam Shirazi
Name of organization / entity
Qazvin Dental school
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3064
Email address
m.shirazi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2017-01-03, 1395/10/14
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of bioactive glass particle adding to the glass ionomer cements in the accumulation of mutans and Lactobacillus around of orthodontic bands
Public title
Anti bacterial effect of bio active glass
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria patient consent for participation in this study; good oral hygiene; absence of active caries or periodontal disease; no mouth breathing;absence of cleft lip or palate; absence of conditions affecting oral microbial flora; absence of conditions affecting tooth brushing and no use of chlorhexidine mouthwash or antibiotics within three weeks prior to this study or during the course of study. Exclusion criteria. Wash out of cement and loosening of appliances
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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,Qazvin university of medical sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin,Iran
City
Qazvin
Postal code
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
ir.qums.rec.1395.300

Health conditions studied

1

Description of health condition studied
Aggregation of bacteria
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
bio active glass
Timepoint
4 months
Method of measurement
sampling

Secondary outcomes

empty

Intervention groups

1

Description
Cement without nano particle
Category
Prevention

2

Description
incorporation of nano particle in orthodontic cement
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin dental school
Full name of responsible person
Maryam Shirazi
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Roya Naseh
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
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, Qazvin 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
Qazvin university of medical sciences
Full name of responsible person
Maryam Shirazi
Position
Assisstant professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 283336001
Fax
Email
Dr.maryam_shirazi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Shirazi
Position
Orthodontist
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
0000000000
Phone
+98 283336001
Fax
Email
Dr.maryam_shirazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin university of medical sciences
Full name of responsible person
Maryam shirazi
Position
Assisstant professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
00000000000
Phone
+98 283336001
Fax
Email
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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