The aim of this study was to evaluate the effect of adding nano silver particles on acrylic base plate of orthodontic removable Retainers on the oral microbial flora. After fixed orthodontic treatment, 60 patients were randomly placed in two groups; group 1 (control group) received conventional removable acrylic plate. Group 2 (intervention group); this group received removable acrylic plate containing silver nano particles. Inclusion criterion: patients who complete their fixed orthodontic treatment and needs removable retainer. Exclusion criteria: smoking habits; presence of active caries or periodontal pockets; systemic diseases; antibiotics; prosthetic appliances. When the removable plate was delivered to the patient and 50 days after, dental plaque samples were taken from patients and cultured. The results were analyzed using paired T-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309239086N2
Registration date:2013-11-09, 1392/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-09, 1392/08/18
Registrant information
Name
Nasrin Farhadian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4017
Email address
farhadian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Dentistry, Hamedan University of Medical Sciences
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of application of nano-silver particles in acrylic base plate of orthodontic removable retainers on oral microflora
Public title
Antimicrobial effect of nano silver particles
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: patients who complete their fixed orthodontic treatment and needs removable retainer.
Exclusion criteria: smoking habits; presence of active caries or periodontal pockets; systemic diseases; antibiotics and prosthetic appliances.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 of Hamedan university of medical sciences
Street address
Hamadan , university of medical sciences
City
Hamadan
Postal code
Approval date
2013-10-29, 1392/08/07
Ethics committee reference number
2401/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Streptococcus mutans bacteria
Timepoint
When the removable plate was delivered to the patient and 50 days after
Method of measurement
cfu/saliva culture
2
Description
Candida albicans
Timepoint
At the end of study
Method of measurement
Colony count
Secondary outcomes
empty
Intervention groups
1
Description
Control group: received conventional orthodontic retainer and The patient was instructed to use her/his retainer full-time except when eating and brushing.Oral hygene will be instructed for all patients, including brushing with toothpaste containing fluoride . Dental biofilm sample of upper arch at the time of retainer delivery and after 50 days use of retainer(end of study) will be obtained for colony count and evaluated in culture medium.Also at the end of study upper removable retainer will be sent for candida assessment.
Category
Treatment - Devices
2
Description
Intervention group: similar as control group but they will receive removable orthodontic retainer containing nano silver particle and patient was instructed to use her/his retainer full-time except when eating and brushing. Oral hygene will be instructed for all patients, including brushing with toothpaste containing fluoride . Dental biofilm sample of upper arch at the time of retainer delivery and after 50 days use of retainer(end of study) will be obtained for colony count and evaluated in culture medium.Also at the end of study upper removable retainer will be sent for candida assessment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Hamadan university ,private orthodontic clinic
Full name of responsible person
Nasrin Farhadian
Street address
Dental school of Hamadan university , Shahid Fahmide Blvd. Hamadan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Faculty of Dentistry, Hamedan University of Medical Sciences, Shahid fahmide blv
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of dentistry, Hamedan 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
Hamedan University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Nasrin Farhadian
Position
Associated professor
Other areas of specialty/work
Street address
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamedan
Postal code
6517838677
Phone
+98 81 1836 4017
Fax
Email
nasrinne@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
Associated professor
Other areas of specialty/work
Street address
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamedan
Postal code
6517838677
Phone
+98 81 1838 1084
Fax
+98 81 1838 1085
Email
farhadian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
Associated professor
Other areas of specialty/work
Street address
Orthodontic dept., Dental faculty, Hamadan University of Medical Sciences , Shahid Fahmide blv.
City
Hamedan
Postal code
6517838677
Phone
+98 81 1838 1084
Fax
Email
farhadian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)