The antimicrobial efficacy of combination of chlorhexidine and triphala mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial)
Antimicrobial efficacy of combination of chlorhexidine and Triphala mouthwashes on orthodontic patients
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 2 on 54 patients. Excel software rand function will be used for randomization.
Settings and conduct
This double-blind study is a randomized clinical study designed to evaluate the effectiveness of 3 types of mouthwash and will be performed during 14 days in the orthodontic department of Tabriz Dental School. From the patients who refer to the orthodontic department, 54 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: Triphala C: Combined Triphala and Chlorhexidine mouthwash. for example ACB ABC BAC ABC...............
Patients will be randomly assigned to three groups.
For this purpose, mouthwash will be poured into similar plastic containers of the same size. The patient and the researcher will not be aware of the type of mouthwash.
Participants/Inclusion and exclusion criteria
Patients in the 20-60 age range; patients agreed with the informed written consent previous to the study; patients with fixed orthodontics; Do not have systemic diseases.
Intervention groups
Group 1 (n = 18): Chlorhexidine mouthwash 0.2%
Group 2 (n = 18):Triphala 0.06%
Group 3 (n = 18): Mouthwash containing a mixture of 0.1% chlorhexidine and Triphala 0.06%
Main outcome variables
Time; The number of bacteria; Studied groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210802052055N1
Registration date:2021-09-22, 1400/06/31
Registration timing:retrospective
Last update:2021-09-22, 1400/06/31
Update count:0
Registration date
2021-09-22, 1400/06/31
Registrant information
Name
Iran Karimzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4244 5322
Email address
baran.m2025@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-07, 1400/05/16
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The antimicrobial efficacy of combination of chlorhexidine and triphala mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial)
Public title
Antimicrobial efficacy of combination of chlorhexidine and Triphala mouthwashes on orthodontic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the 20-60 age range
patients agreed with the informed written consent previous to the study
patients with fixed orthodontics
Do not have systemic diseases
Exclusion criteria:
Patients with dental prostheses (crown and bridge)
Patients with soft tissue pathology
Patients with poor oral health (DMFT> 8)
Smokers
periodentitis
Pregnancy and Breastfeeding
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients to the study groups, permuted block randomization method will be used with three patients in each block. The sample of the created list is as follows: BCA BAC CAB BCA CAB .........
From the patients who refer to the orthodontic department, we select 54 people who meet the admission criteria and provide them with the consent form to complete.
Random allocation software was used for randomization and allocation.Each eligible patient is assigned to one of the three study groups, based on the list provided to the head of the faculty. Patients receive their mouthwash according to the letters of each block: A): Chlorhexidine: B triphala C Composite triphala and Chlorhexidine Mouthwash)
Patients will be randomly assigned to three groups.
Group 1 (n = 18): Chlorhexidine mouthwash 0.2%
Group 2 (18 people): Trifala mouthwash
Group 3 (n = 18): Mouthwash containing a mixture of 0.1% chlorhexidine and Trifala
For this purpose, mouthwash will be poured into similar plastic containers of the same size. The patient and the researcher will not be aware of the type of mouthwash.
Blinding (investigator's opinion)
Double blinded
Blinding description
Mouthwash will be poured into similar plastic containers of the same size and the letters A, B, C will be written on them by the secretary of the department and will be delivered to the patients according to the randomized list. The patients 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
Colony counting unit (The number of colonies formed is counted by CFU method)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group (n = 18): Chlorhexidine mouthwash 0.2% 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
2
Description
Intervention group: The second group (n = 18): triphala0.06% 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
3
Description
Intervention group: The third group (n = 18): Mouthwash containing 0.1% chlorhexidine mixture and triphala 0.06% 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