The antimicrobial efficacy of combination of chlorhexidine and nano-silver fluoride mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial)
The aim of this study is to evaluate the antimicrobial efficacy of using the combination of chlorhexidine and nano-silver fluoride mouthwashes for 14 days on Streptococcus mutans in patients undergoing orthodontic therapy
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 1on 45 patients. Excel software rand function is used for randomization.
Settings and conduct
This randomized double-blind study is designed to evaluate the efficacy of 3 mouthwashes and will be performed in 14 days in the orthodontic department of Tabriz Dental School. From the patients who refer to the orthodontic department, 45 people who meet the inclusion criteria will be selected and will be asked to fill out the written consent form.
Patients will use 10 ml of mouthwash 2 times a day. They should wait 30 minutes to eat or drink.
Saliva samples will be collected in sterile containers two times with one week interval.
Mouthwashes will be poured into similar plastic containers.The patient and the researcher will not be aware of the type of mouthwash.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients not receiving antibiotic therapy for the past three weeks
Patients not receiving fluoride therapy for the past three weeks patients agreed with the informed written consent previous to the study
Patients in the 20-40 age range
Exclusion criteria:
Patients with dental prostheses (crown and bridge)
Patients with soft tissue pathology
Patients with poor oral health (DMFT> 8)
Smokers
Patients with orthodontic removable appliances
Intervention groups
Group 1(n=15): Chlorhexidine mouthwash 0.2%
Group 2 (n=15): Silver fluoride nanoparticles mouthwash 0.04%
Group 3 (n=15): Mouthwash containing a mixture of 0.1% chlorhexidine and silver fluoride nanoparticles (400 ppm)
Main outcome variables
Time, amount of bacteria, Study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210620051635N1
Registration date:2021-07-30, 1400/05/08
Registration timing:retrospective
Last update:2021-07-30, 1400/05/08
Update count:0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
Yasaman Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 2244 5321
Email address
yasamanazizi97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The antimicrobial efficacy of combination of chlorhexidine and nano-silver fluoride mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial)
Public title
Antimicrobial efficacy of combination of chlorhexidine and nano-silver fluoride mouthwashes on orthodontic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients not receiving antibiotic therapy for the past three weeks
Patients not receiving fluoride therapy for the past three weeks
patients agreed with the informed written consent previous to the study
Patients in the 20-40 age range
Exclusion criteria:
Patients with dental prostheses (crown and bridge)
Patients with soft tissue pathology
Patients with poor oral health (DMFT> 8)
Smokers
Patients with orthodontic removable appliances
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients to the study groups, permuted block randomization method was used with three patients in each block.The created list is as follows:
ACB ABC BAC ABC BCA BAC CAB BCA CAB ACB ABC CBA CAB CBA ACB
The results will be reported by mean ± standard deviation and frequency percentage. Shapiro-Wilk test will be used to analyze the normality of the data. In order to compare the amount of bacteria in the study groups, analysis of variance of covariance will be used. A probability of less than 5% will be considered a significant level. For data analysis, SPSS software version 20 will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This double-blind study is a randomized clinical study designed to evaluate the effectiveness of 3 mouthwashes and will be performed during 14 days in the orthodontic department of Tabriz Dental School. From the patients who refer to the orthodontic department, 45 people who meet the inclusion criteria will be selected and they will be asked to fill out the written consent form.
Random allocation software will be used for randomization and allocation. Each eligible patient will be assigned to one of the three study groups, based on the list kept by the head of the faculty. Patients will receive their mouthwashes according to the letters of each block: A: Chlorhexidine B:Silver fluoride nano-particles C: Combined nano-silver fluoride and Chlorhexidine mouthwash
ACB ABC BAC ABC BCA BAC CAB BCA CAB ACB ABC CBA CAB CBA ACB
Patients will be randomly assigned to three groups.
Group 1 (n = 15): Chlorhexidine mouthwash 0.2%
Group 2 (n = 15): Silver fluoride nano-particles mouthwash 0.04%
Group 3 (n = 15): Mouthwash containing a mixture of 0.1% chlorhexidine and silver fluoride nano-particles (400 ppm)
For this purpose, mouthwash will be poured into similar plastic containers with the same size. The patient and the researcher will not be aware of 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 Tabriz University of Medical Sciences
Before intervention - 14 days after the intervention (Using Mouthwash)
Method of measurement
Time: 2 times (before and after using mouthwash (first day and 14th)) Bacterial content: Colony counting unit study groups: Chlorhexidine, silver fluoride, combination of Chlorhexidine and silver fluoride
Secondary outcomes
1
Description
Time, The amount of bacteria, Study groups
Timepoint
2 times (before intervention and 14 days after intervention)
Method of measurement
Time: 2 times (before intervention _ 14 days after intervention) Bacterial content: colony-forming unit Study groups: 2 times (before intervention _14 days after intervention)
Intervention groups
1
Description
The first group (n = 15): Chlorhexidine mouthwash 0.2% , The second group (n = 15): Silver fluoride mouthwash 0.04% ,The third group (n = 15): Mouthwash containing 0.1% chlorhexidine mixture and silver fluoride nanoparticles (400 ppm) All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics , Faculty of Dentistry, Tabriz University of Medical Sciences