Comparing the effect of zinc(1%), chlorhexidine (0/2%)and propolis mouthwashes on periodontal indices of children undergoing preventive orthodontic treatment
Determining the effect of three mouthwashes containing zinc ,chlorhexidine(0/2%) and propolis on periodental indices in children undergoing preventive orthodontic treatment
Design
clinical trial without blinded group and crossover designed of 16 patiants
Settings and conduct
16 children 8 to 12 years old will be selected from the patients of dental school of Qazvin University of Medical Sciences who use mandible lingual arch. After presenting the necessary explanations, written consent will be taken from the parents. each of Zinc ,Propolis and Chlorhexidine Mouthwashes will be used for a period of one week, after which the PI and GI indices on the deciduous teeth will be measured. patients will be asked to brush their teeth three times a day as instructed. The mouthwash is gargle for 30 seconds half an hour after using the toothbrush. After using the mouthwashes, they dont wash their mouth and also dont eat anything. Avoid using toothpaste containing fluoride for an hour before using mouthwashes. After using each mouthwash , it should be a period of two weeks as washout
Participants/Inclusion and exclusion criteria
16 children 8 to 12 years old with lingual arch appliance in their mandible
Inclusion criteria:
Patiant willingness to cooperate with research
Do not suffer from disease that weaken the immune system
Do not suffer from various systemic disease
Do not receive antibiotics at least one month before and during the research priod
Do not use mouthwash in the past month
Absence of periodontitis and do not receive periodontal treatments in the last 6 months
Exclusion criteria:
Sensivity to mouthwashes
Participants are reluctant to continue the process of using mouthwashes
Intervention groups
All of participanta recieve three types of mouthwashes
Main outcome variables
Decrease of plauqe index;Decrease of gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210913052460N1
Registration date:2021-09-20, 1400/06/29
Registration timing:registered_while_recruiting
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
zahra fotouhi qazvini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3357 1036
Email address
z.fotohighazvini@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2021-09-29, 1400/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of zinc(1%), chlorhexidine (0/2%)and propolis mouthwashes on periodontal indices of children undergoing preventive orthodontic treatment
Public title
Comparing the effect of three types of mouthwashes on periodontal indices of children undergoing orthodontic treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient willingness to cooperate with research
Do not suffer from disease that weaken the immune system
Do not suffer from various systemic disease
Do not recieve antibiotics at least one month before and during the study period
Absence of periodontitis and receiving periodental treatment in the last six months
Exclusion criteria:
Sensivity to mouthwashes
Participants are reluctant to continue the process of using mouthwashes
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ًQazvin University of Medical Sciences
Street address
No.69 ,Azimian Ave.,Tehranqadim St.,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3418683746
Approval date
2021-08-11, 1400/05/20
Ethics committee reference number
IR.QUMS.REC.1400.220
Health conditions studied
1
Description of health condition studied
periodental indices
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plaque index
Timepoint
Beginning of research,7 days after using each mouthwash,with two weeks washout
Method of measurement
sillness and loe,with periodontal probe
2
Description
gingival index
Timepoint
Beginning of research,7 days after using each mouthwash,with two weeks washout