1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Comparative antiplaque effectiveness of Meridol (amin fluoride/stannous fluoride) and Kids Irsha in 7-9 year-old school children referred to
Community Dental Health Department of Zahedan Dental School in 2010-2011
Protocol summary
Summary
Use of antimicrobial mouth rinses as adjuncts to mechanical oral hygiene are strongly recommended.
Meridol and Irsha as two antibacterial mouth rinses lacking the side effects of chlorhexidine mouth rinse and with the ability of fluoride releasing have been widely marketed during the recent years. The aim of this study is to compare the effect of Meridol and Kids’ Irsha mouth rinses on plaque accumulation. In this single blind, randomized clinical trial that having placebo, Forty-five children aged 7-9 years without dental crowding, developmental dental anomalies, large dental caries or defective restorations who brush and floss daily were recruited. Subjects were randomly assigned to one of the four groups: Meridol, Irsha, chlorhexidine and saline. A dental prophylaxis was performed for each child and 48 hours after prophylaxis on day 0 and 30, subjects were examined and percentage of plaque index reduction was compared in different groups through Kruskal-Wallis and Mann–Whitney tests. Plaque index was reduced
significantly in all four groups on day 30 compared to day 0. Percent of plaque reduction between days 0 and 30 was not significant in Kids Irsha and Meridol groups compared to each other and Saline, whereas
Chlorhexidine showed significant difference with Meridol, Kids Irsha and Saline. This study revealed that the effect of Meridol and Kids Irsha mouth rinses on percent of plaque index reduction compared to Chlorhexidin is not significant.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT201103256105N1 Registration date: 2011-06-20, 1390/03/30
Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2011-06-20, 1390/03/30 Registrant information
Name
Nahid Ramazani
Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 54 1341 6706 Email address
ramazani77@zaums.ac.ir Recruitment status
Recruitment complete Funding source
Vice chancellor for research, Zahedan University of Medical Science
Expected recruitment start date 2011-04-21, 1390/02/01
Expected recruitment end date 2011-06-22, 1390/04/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparative antiplaque effectiveness of Meridol (amin fluoride/stannous fluoride) and Kids Irsha in 7-9 year-old
2 school children referred to Community Dental Health
Department of Zahedan Dental School in 2010-2011 Public title
Effect of Meridol and Kids Irsha mouth rinses on the amount of plaque accumulation in children
Purpose Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Daily tooth brushing and flossing; No mouth rinse application during the last month; No antibiotic treatment within the last 2 weeks; Not wearing any orthodontic appliances Exclusion criteria: Presence of dental crowding; Presence of dental developmental anomalies; Presence of large dental caries or defective restoration
Age
From 7 years old to 9 years old Gender
Both Phase
2
Groups that have been masked No information
Sample size
Target sample size: 45
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Single blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
It does not registered any where Secondary trial Id
It does not have Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Science
Street address
Daneshga avenue, Dr Hesabi square, pardis of University of Medical Science
City
Zahedan Postal code Approval date
2010-06-12, 1389/03/22
Ethics committee reference number 822-89
Health conditions studied
1
Description of health condition studied dental plaque
ICD-10 code K02.9
ICD-10 code description Dental caries, unspecified
Primary outcomes
1
Description dental plaque Timepoint
before and one month after intervention Method of measurement
according to Green & Vermellion plaque index
Secondary outcomes empty
Intervention groups
1
Description
Intervention 1: Meridol (Germany), for one month (30 days), 10 ml mouth rinse in each application, once a day, for 30 seconds
Category Prevention
2
Description
Intervention 2: Kids’ Irsha (Iran), for one month (30 days), 15 ml mouth rinse in each application, twice a day, for 30 seconds
Category Prevention
3
Description
Intervention 3: Chlorhexidine 0.2% (Iran), for one month (30 days), 7 ml mouth rinse in each application, twice a day, for 30 seconds
Category Prevention
3
4
Description
Control: saline (Iran), for one month (30 days), 15 ml mouth rinse in each application, twice a day, for 30 seconds
Category Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Community Dental Health Department of Zahedan Dental School
Full name of responsible person Dr. Nahid Ramazani
Street address
Pediatric Department, Dental School City
Zahedan
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Science
Full name of responsible person Dr. Mahmud Zade Sagheb Street address
Pardis of Zahedan University of Medical Sciences, Khalij e Fars Avenue, Dr. Hesabi Square
City Zahedan 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, Zahedan University of Medical Science
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
Zahedan University of Medical Sciences Full name of responsible person
Dr. Nahid Ramazani Position
Assistant professor of pediatric dentistry Other areas of specialty/work
Street address
Mehr avenue, Dental School City
Zahedan Postal code Phone
+98 54 1242 3218 Fax
+98 54 1241 4003 Email
ramazani@zaums.ac.ir; ramazani77@gmail.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences Full name of responsible person
Dr. Nahid Ramazani Position
Pedodontist
Other areas of specialty/work Street address
Mehr avenue, Dental School City
Zahedan Postal code Phone
+98 54 1242 3218 Fax
+98 54 1241 4003 Email
ramazani@zaums.ac.ir; ramazani77@gmail.com Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty
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Data Dictionary empty
