Comparison of the effect of chlorhexidine mouthwash and sodium fluoride mouthwash on gum health after stainless steel crowns in primary teeth.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 30 patients.
Settings and conduct
The study is conducted in the children's department of the dental clinic of Ilam University of Medical Sciences on children aged 6 to 12 years.
30 patients are divided into two equal groups. The amount of plaque index and gingival index around the decayed tooth is measured. chlorhexidine and sodium fluoride mouthwashes are applied twice a day for a week with an ear cleaner around the ssc cover done at the college. At the end, plaque index and gingival index are calculated.
Participants/Inclusion and exclusion criteria
log in :
Children 6 to 12 years old
At least 1 primery tooth needs ssc coating
Failure to enter:
Systemic disease
Dental crowding
Intervention groups
Case group: sodium fluoride mouthwash is used on the gums around the ssc
Control group: Chlorhexidine mouthwash is used on the gums around the ssc
Main outcome variables
Determination of plaque index and gingival index in the group treated with chlorhexidine mouthwash
Determining plaque index and gingival index in the group treated with sodium fluoride mouthwash
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230122057176N1
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Mobin Nikoonahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3224 6899
Email address
nikoonahad.mobin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-26, 1402/04/05
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparsion of the effect of Chlorhexidine mouthwash and sodium fluoride mouthwash on gingival healing around stainless steel crown in primary teeth
Public title
comparsion of the effect of Chlorhexidine mouthwash and sodium fluoride mouthwash on gingival healing around stainless steel crown in primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 to 12 year old child
Having at least 1 posterior primary tooth that requires a stainless steel crown
Exclusion criteria:
Child with systemic disease
Child with dental crowding
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient : the patient does not know the type of mouthwash. After obtaining the consent form from the patient, the relevant mouthwash is poured into special containers that have been prepared in advance and the type of mouthwash inside is not known and is delivered to the patient for use.
Outcome assessor :the type of mouthwash is not mentioned in the evaluation form and only the patient's code is written. In a separate list, in front of each patient's name, the relevant code and the name of the mouthwash are written so that the analyzer can use that list to perform the analysis. In this way, the evaluator does not know the name of the patient and the type of mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
6939177143, Pegohesh Boulevard, Banganjab, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.MEDILAM.REC.1402.058
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Plaque index
Timepoint
At the beginning of the study and 7 days after the intervention
Method of measurement
Turesky modification of the Quigley-Hein method
2
Description
Gingival index
Timepoint
At the beginning of the study and 7 days after the intervention
Method of measurement
Löe & silness method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: vi one mouthwash made by Rogin company is used for one week and twice a day in children 6 to 12 years old.
Category
Treatment - Drugs
2
Description
Control group: chlorhexidine mouthwash made by Rogin company is used for one week and twice a day in children 6 to 12 years old.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ilam University of Medical Sciences
Full name of responsible person
Mobin Nikoonahad
Street address
6939177143, Pegohesh Boulevard, Banganjab, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abas Maleki
Street address
6939177143, Pegohesh boulevard, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
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
Ilam University of Medical Sciences
Full name of responsible person
Mobin Nikoonahad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
6931133559, Niaz avenue, Namaz Boulevard, Ilam
City
Ilam
Province
Ilam
Postal code
6931133559
Phone
+98 84 3224 6899
Email
nikoonahad.mobin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mobin Nikoonahad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
6931133559, Niaz avenue, Namaz Boulevard, Ilam
City
Ilam
Province
Ilam
Postal code
6931133559
Phone
+98 84 3224 6899
Email
nikoonahad.mobin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mobin Nikoonahad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
6931133559, Niaz avenue, Namaz Boulevard, Ilam
City
Ilam
Province
Ilam
Postal code
6931133559
Phone
+98 84 3224 6899
Email
nikoonahad.mobin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Full can be published
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Only people working in academic institutions
Under which criteria data/document could be used
No analysis is allowed
From where data/document is obtainable
Mobin Nikoonahad
nikoonahad.mobin@gmail.com
What processes are involved for a request to access data/document