Determining the Effect of Chlorhexidine Releasing Elastomeric Ligatures on the Number of Streptococcus Mutants in Orthodontic Patients
Design
A randomized, double-blind, placebo-controlled clinical trial of 30 patients.
Settings and conduct
In this study, 30 patients in need of fixed orthodontic treatment referred to the dental clinic were selected. The patients were randomly divided into control and intervention groups. Normal elastomeric ligature in the control group and chlorhexidine-releasing elastomers in the intervention group were used. The study is double-blind. Participant and outcome assessor (microbiologist) and data analyzer are unaware of who is in what group and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who need fixed orthodontic treatment
Exclusion criteria: Receive any antibiotics or other medication, fluoride treatment during the previous two weeks, any systemic illness, prosthetic or soft tissue lesions, and common caries.
Intervention groups
In the intervention group, chlorhexidine-releasing elastomerics were used. Chlorhexidine-releasing elastomeric ligatures were used twice at baseline and 28 days after baseline study.
Main outcome variables
Streptococcus mutans bacteria in saliva
Streptococcus mutans bacteria count at the surface of elastomeric ligation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041837N1
Registration date:2020-02-26, 1398/12/07
Registration timing:retrospective
Last update:2020-02-26, 1398/12/07
Update count:0
Registration date
2020-02-26, 1398/12/07
Registrant information
Name
somayeh mehrabi koushki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 1760
Email address
somaye.mehrabi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-02, 1398/02/12
Expected recruitment end date
2019-08-19, 1398/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of chlorhexidine-releasing elastomerics on Streptococcus mutans Levels in orthodontic patients Saliva
Public title
Effect of chlorhexidine-releasing elastomerics on Streptococcus mutans Levels in orthodontic patients Saliva
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with fixed orthodontic treatment
Exclusion criteria:
existence of any systemic disease,
Use antibiotics and other medication within two weeks before starting the study
existence prosthodontic appliances,
existence soft tissue lesions
existence rampant caries
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients in need of fixed orthodontic treatment referring to dental clinic were randomly divided into two groups of intervention and control by a non-researcher. Individuals were divided into two groups of 15 individuals, each numbered from 1 to 30, and then randomly divided into two groups using random allocation software. Information about each individual was stored in numbered envelopes that were similar in appearance.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double blind study. Chlorhexidine-releasing elastomerics and conventional elastomerics were quite similar in appearance and color. Patients received their elastomeric according to the assigned number. Patients were completely unaware of the elastomeric type. Saliva samples were given to microbiologists in similar containers. The microbiologist and the statistical analyzer were unaware of what elastomeric each patient used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Dentistry, Islamic Azad University, Isfahan (Khorasgan) Branch
Street address
Islamic Azad University,Khorasgan Branch University Blvd, Arqavanieh, Jey Street Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.121
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
Colony Forming Unit (CFU) of Streptococcus mutans in saliva
Timepoint
baseline, and 7, 14, 21 and 28 days after the intervention
Method of measurement
Saliva sample collection for culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Orthodontic elastomers using the combination of chlorhexidine diacetate as an antibacterial agent and ethyl cellulose as the polymer. The volume of polymer used was 2%. Chlorhexidine-releasing elastomeric ligatures were used twice at baseline and 28 days after baseline study.
Category
Prevention
2
Description
Control group: conventional elastomeric ligatures were
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University (Khorasgan Branch), Orthodontic Department
Full name of responsible person
Dr. Somayeh Mehrabi
Street address
Dental school, Isfahan Azad University (Khorasegan branch), Arghavanieh Blvd.
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 3535 4004
Email
somaye.mehrabi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Amir Mansour Shirani
Street address
Dental school, Isfahan Azad University (Khorasegan Branch), Arghavanieh Blvd.
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 3535 4053
Email
hshirali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dental school
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
Islamic Azad University
Full name of responsible person
Somayeh Mehrabi Koushki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 28 Nasr St. Valieasr Sq.
City
Tehran
Province
Tehran
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 8880 1760
Fax
Email
somaye.mehrabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Mehrabi Koushki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 28 Nasr St. Valieasr Sq.
City
Tehran
Province
Tehran
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 8880 1760
Fax
Email
somaye.mehrabi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Mehrabi Koushki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 28 Nasr St. Valieasr Sq.
City
Tehran
Province
Tehran
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 21 8880 1760
Fax
Email
somaye.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
File of Intervention program protocol and Statistical analysis plan through the publication of the thesis or writing an article
When the data will become available and for how long
Starting 6 months after publication of results.
To whom data/document is available
Research team of this study and other clinical academic researchers who are studying in favor of these patients
Under which criteria data/document could be used
Researchers who intend to write a meta-analysis or systematic review articles are allowed to access documents
From where data/document is obtainable
Dr. Somayeh Mehrabi (somaye.mehrabi@gmail.com)
What processes are involved for a request to access data/document
The request will be responsed after getting the approval of university or the Academic Institution