In this study we aimed to compare persica herbal mouthwash effects in reduction of streptococcus mutans in saliva and in plaque of primary school children with chlorhexidine.This randomized clinical trial was done on 50 primary school (6 to 12 years) children who were living in Fayyaz bashkh Mashhad child care center, Hashemi nezhad center, Fereshtegan center and Shahid Beheshti center who have moderate and weak oral hygiene but high caries risk and did not use of mouthwash and antibiotic in 3 weeks ago .children randomly assigned to one of the persica or chlorhexidine groups.at baseline samples from saliva and plaque were collected. After one week use of mouthwashes the samples were repeated. The streptococcus mutans count in saliva and plaque as well as saliva PH and plaque index were recorded in both times.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030532881N1
Registration date:2017-06-15, 1396/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-15, 1396/03/25
Registrant information
Name
Zahra Mohammadzadeh
Name of organization / entity
Mashhad dental school
Country
Iran (Islamic Republic of)
Phone
+98 51 3662 9015
Email address
mohammadzadehz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of persica and chlorhexidine mouthwash in reducing salivary and plaque streptococcus mutans in primary school children.
Public title
Comparison the effect of persica and chlorhexidine mouthwash.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: primary school children with high caries risk ; without use of antibiotic and mouthwash in 3 weeks ago.
exclusion criteria: use of antibiotic and mouthwash ; lack of cooperation
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of mashhad university of medical sciences
Street address
Mashhad univer sity of medical sciences,Daneshgah St. – Mashhad – Iran
City
Mashhad
Postal code
91735
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.mums.sd.REC.1395.139
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
streptococcus mutans counts in dental plaque
Timepoint
at baseline and after 1 week ude of mouthwash
Method of measurement
microbial culture
2
Description
streptococcus mutans counts in saliva
Timepoint
at baseline and after 1 week ude of mouthwash
Method of measurement
bacterial cilture
3
Description
dental plaque
Timepoint
at baseline and after 1 week ude of mouthwash
Method of measurement
Loe&Sillness scale
4
Description
saliva ph
Timepoint
at base line and after 1 week use of mouthwash
Method of measurement
ph meter
Secondary outcomes
empty
Intervention groups
1
Description
in intervention group Persica mouthwash was prescribed for 25 children who have weak and moderate oral hygiene but high caries risk .mouthwash was diluted by pharmacist before prescription ,according to factory instruction .this means that one drop of Persica in one cc water and the children were asked to rinse twice a day with 15 mlit for 60 seconds. at baseline samples from saliva and plaque were collected. After one week use of mouthwashes the samples were repeated. The streptococcus mutans counts in saliva and plaque as well as saliva PH and plaque index were recorded in both times.
Category
Prevention
2
Description
in control group 0.12% Chlorhexidine mouthwash was prescribed for 25 children who have weak and moderate oral hygiene but high caries risk and the children were asked to rinse once a day with 15 mlit for 60 seconds.at baseline samples from saliva and plaque were collected. After one week use of mouthwashes the samples were repeated. The streptococcus mutans counts in saliva and plaque as well as saliva PH and plaque index were recorded in both times.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
fereshtegan house
Full name of responsible person
MS Ramezan zade
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
fayyaz bakhsh home
Full name of responsible person
Ms Molayi
Street address
City
Mashhad
3
Recruitment center
Name of recruitment center
shahid beheshti center
Full name of responsible person
Mr Hashemi
Street address
City
Mashhad
4
Recruitment center
Name of recruitment center
Hashemi nezhad center
Full name of responsible person
Ms Ghorbani
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research chancellor of Dental School of Mashhad University of Medical Sciences , Malihe Razm Avar
Street address
Mashhad University of Medical Sciences, Vakil Abad Bolvard, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Faculty of dentistry , Mashhad University of Medical Sciences
Full name of responsible person
Zahra Mohammadzadeh
Position
assisstant professor
Other areas of specialty/work
Street address
Pediatric department of dental school.Vakil abad bolvard , Mashhad , Iran
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
mohammadzadehz@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Dental School
Full name of responsible person
Zahra Mohammadzadeh
Position
pedodontist
Other areas of specialty/work
Street address
Faculty of Dentistry , Mashhad University of Medical Sciences , Vakil abad bolvard , Mashhad , Iran
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
mohammadzadehz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Zahra Mohammadzadeh
Position
Pedodontist
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences , Vakil abad bolvard , Mashhad , Iran
City
Mashhad
Postal code
Phone
00
Fax
Email
mohammadzadehz@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)