The aim of the study is to assess the effect of fluoride containing chlorhexidine 0.12% on dental plaque index(PI), gingival and stain index(GI,SI) in patients referred to Periodontal department, School of dentistry, Golestan University of Medical Sciences.
This study is a randomized, parallel, double blind study. The patients are 50-18 years old.
Patients are randomly assigned into two groups. In one group chlorhexidine 0.12% (laboratories world of health, Iran) is prescribed and another group are asked to use chlorhexidine0.12% + Sodium fluoride 0.05% (EMAD Pharma, Iran), twice daily for 2 weeks and refrain from eating for half an hour. PI, GI and SI are recorded by a blinded clinician before and after the use of mouthrinses. Data are analyzed using SPSS16.
General information
Acronym
Evaluation of the effect of fluoride containing 0.12% chlorhexidine
IRCT registration information
IRCT registration number:IRCT2016110630744N1
Registration date:2017-04-05, 1396/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Elham Fakhari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3227 2253
Email address
dr.fakhari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Golestan university of medical sciences
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of fluoride containing 0.12% chlorhexidine on dental plaque, gingival and stain index in the patients
Public title
The effect of fluoride containing chlorhexidine on the gingival health
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: presence of 20 teeth except wisdom teeth in the mouth, pocket depth <5 mm , Attachment loss <2 mm.
exclusion criteria: 1. pathological lesions of the oral mucosa 2. use of mouthwash in a study last month 3- systemic disease effective on periodontal condition 4-history of allergy to chlorhexidine 5-partial denture or ortodontic applience
Age
No age limit
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
Not used
Assignment
Parallel
Other design features
Random with random numbers table
Secondary Ids
1
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
in front of Edalat97, Gorgan dentistry school, Gorgan, post code:49169-53363
City
Gorgan
Postal code
49169-53363
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.goums.REC.1395.145
Health conditions studied
1
Description of health condition studied
dental plaqe,gingival inflamation,dental color change
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
gingival inflamation
Timepoint
first day and seventh day and The fifteenth day of intervention
Method of measurement
gingival index(loe&silness)
2
Description
dental plaqe
Timepoint
first day and seventh day and The fifteenth day of intervention
Method of measurement
plaqe index(loe&silness)
3
Description
dental color change
Timepoint
first day and seventh day and The fifteenth day of intervention
Method of measurement
color change index DI,Brecx et al
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: mouthwash chlorhexidine 0.12% + sodium fluoride0.05%(EMAD pharma,Iran)
twice daily for 2 weeks and refrain from eating for half an hour
Category
Treatment - Drugs
2
Description
control Group: mouthwash chlorhexidine 0.12% (laboratories world of health, Iran)
twice daily for 2 weeks and refrain from eating for half an hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
periodontal department, School of dentistry, Golestan University of Medical Sciences
Full name of responsible person
Dr Elham Fakhari
Street address
in front of Edalat97, Gorgan, postcode:49169-53363
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Golestan University of Medical Sciences
Full name of responsible person
Dr Mohamad Hossein Taziki
Street address
First shastkola,km 5 Gorgan
City
Gorgan
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 of Golestan 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
school of dentistry, Golestan university of medical science
Full name of responsible person
Dr Elham Fakhari
Position
assisstant professor Periodontics
Other areas of specialty/work
Street address
gorgan-in front of Edalat 97-dentistry clinic of golestan university of medical science
City
gorgan
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
dentistry school of golestan university of medical science
Full name of responsible person
Dr Elham Fakhari
Position
Professor of Periodontics
Other areas of specialty/work
Street address
Gorgan-in front of Edalat 97-Gorgan dentistry school
City
gorgan
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address
www.goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
49169-53363
Phone
+98 17 3255 0700
Fax
+98 17 3255 0702
Email
Dr.fakhari@goums.ac.ir
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)