The purpose of this study is to determine the effect of Chlorhexidine gel and Fluoride varnish on plaque and gingival indices and also their influence on white spots prevention in fixed orthodontics patients. The main Inclusion criteria is having a non-extraction orthodontic treatment and the main Exclusion criteria is the disability of performing hygenic instructions. In this study 40 patients will be divided into groups of 10 including: Chlorhexidine gel, Fluoride varnish, Control and Placebo.The type of study is double blind and randomization is done by table of random numbers. This is a single center clinical trial. Fluoride varnish is applied in one group, Chlorhexidine gel in the other and Placebo to the placebo group.The parameters wil be measured four times in every 3 months in this manner: before first intervention, 3, 6 and 9 months after that. The parameters will be measured before the interventions in each time. The patients must have fix appliances in both jaws and need a Non-extraction treatment. The parameteres that will evaluate include: gingival index, plaque index and white spot index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122531558N1
Registration date:2017-06-24, 1396/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Navid Yaraghi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5543
Email address
alavi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial of Comparing The effect of Fluoride varnish and Chlorhexidine gel on white spots and gingival indexes in orthodontic patients.
Public title
Effect of preventive agents on oral health in orthodontic patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 18; permanent dentition in both jaws; Fixed appliances in both jaws at least 8 anterior teeth; Non extraction treatment.
Exclusion criteria: Showing allergic reaction to used materials; history of previous orthodontic treatment; systemic disease affecting teeth such as Amelogenesis and Dentinogenesis Imperfecta; history of using drugs affecting plaque accumulation ,saliva secretion and gingiva; syndromes or systemic diseases associating with inflammatory processes (Licken planus,Lupus,Pemphigoid diseases); Patients who are not able to perform the hygiene instructions.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
81746-73461
Approval date
2016-01-30, 1394/11/10
Ethics committee reference number
IR.MUI.REC.1394.3.866
Health conditions studied
1
Description of health condition studied
Dental white spot lesion
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
2
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivits
Primary outcomes
1
Description
White spots
Timepoint
Before the first intervention, 3, 6 and 9 months after that and before the intervention in each time.
Method of measurement
Visual inspection with intra oral examination mirror
2
Description
Gingival index
Timepoint
Before the first intervention, 3, 6 and 9 months after that and before the intervention in each time.
Method of measurement
Dental probe
3
Description
plaque index
Timepoint
Before the first intervention, 3, 6 and 9 months after that and before the intervention in each time.
Method of measurement
Visual inspection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Fluoride varnish %5 which is made in USA will be applied on teeth every 3 months until 9 months.
Category
Prevention
2
Description
Intervention group 2: Chlorhexidine gel 0/2% which is made in Spain,in dose of 5mg will be applied on teeth every 3 months until 9 months.
Category
Prevention
3
Description
Placebo group: Sorbitol solution (70% W/W) will be applied on teeth every 3 month until 9 months.
Category
Prevention
4
Description
Control group: No intervention is done.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic department of Isfahan faculty of dentistry
Full name of responsible person
Navid Yaraghi(Orthodontics resident)
Street address
Faculty of dentistry, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
Dental faculty, Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Grant name
30
Grant code / Reference number
394866
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Navid Yaraghi
Position
Orthodontics resident/Doctor
Other areas of specialty/work
Street address
Dental Faculty, Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
٧٣٤٦١-٨١٧٤٦
Phone
+98 31 3792 5543
Fax
+98 31337925543
Email
navidyaraghi@yahoo.com
Web page address
dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Isfahan University of Medical Sciences
Full name of responsible person
Dr Shiva Alavi
Position
Associate Professor
Other areas of specialty/work
Street address
Dental Faculty, Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3792 5543
Fax
Email
alavi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Navid Yaraghi
Position
Orthodontics resident
Other areas of specialty/work
Street address
Dental Faculty, Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8156635563
Phone
+98 31 3228 7470
Fax
Email
navidyaraghi@yahoo.com
Web page address
dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)