Comparison of the effects of curcumin detergent with chlorhexidine on Streptococcus mutans attached to orthodontic elastic rings in patients undergoing orthodontic treatment
Comparison of the effects of curcumin detergent with chlorhexidine on Streptococcus mutans attached to orthodontic elastic rings in patients undergoing orthodontic treatment
Design
The study population was randomly divided into two groups of 11 patients each. One group received a mouthwash containing 0.2% curcumin, while the control group received 0.2% chlorhexidine mouthwash(24). The mouthwashes were placed in bottles of identical color and shape to blind the patients and dental assistant. Patients were instructed on the Horizontal Scrub technique for oral hygiene and brushing at least twice daily for 2-4 minutes per session. Additionally, all patients were provided with the same toothbrush and toothpaste. They were instructed to rinse their mouth with 5 milliliters of the assigned mouthwash twice daily (morning and night) for 30 seconds for a period of 20 days. Patients were advised not to eat or drink for an hour after rinsing
Settings and conduct
study conducted at the dental school of Mazandaran University of Medical Sciences
Participants/Inclusion and exclusion criteria
orthodontic patient with no periodontal diseases
Patients who were using corticosteroids, or had consumed any antibiotic or mouthwash two weeks were excluded from the study.
Intervention groups
curcumin mouthwash group
chlorhexidine mouthwash group as control
Main outcome variables
streptococus mutans decrease
General information
Reason for update
Acronym
CMS
IRCT registration information
IRCT registration number:IRCT20240408061447N1
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
tahura etezadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3330 2425
Email address
t.etezadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of curcumin detergent with chlorhexidine on Streptococcus mutans attached to orthodontic elastic rings in patients undergoing orthodontic treatment
Public title
Comparison of the effects of curcumin detergent with chlorhexidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
normal gingiva without periodontitis
Exclusion criteria:
no history of mouthwash or antibiotic use in two previous week
no use of corticosteroied
Age
From 15 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
simple random sampling
We used identical bottle for mouthwashes and assistant choose one of them randomly and give it to patients. This method was done after epidemiologist consultation.
Blinding (investigator's opinion)
Double blinded
Blinding description
no information about mouthwash give to patient and scientist.
the mouthwashes were placed in identical bottle.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of mazandaran university of medical sciences
Street address
khazar blvd
City
sari
Province
Mazandaran
Postal code
4817818893
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MAZUMS.REC.1401.522
Health conditions studied
1
Description of health condition studied
effect of curcumin on streptococcus mutan
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
streptococcus mutans
Timepoint
before, immediately after and 20 days after treatment
Method of measurement
colony count
Secondary outcomes
1
Description
oral burning
Timepoint
before, immediately after and 20 days after treatment
Method of measurement
patient asking
Intervention groups
1
Description
Intervention group: curcumin mouthwash , twice a day for 20 days and 5 cc for each time
Category
Treatment - Drugs
2
Description
Control group: cholorhexidine mouthwash, twice a day for 20 days and 5 cc for each time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari dental school
Full name of responsible person
Tahura Etezadi
Street address
Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4817818893
Phone
+98 11 3330 2425
Email
t.etezadi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
dr Pedram Ebrahimnejad
Street address
Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4817818893
Phone
+98 11 3330 2425
Email
t.etezadi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahura Etezadi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
orthodontics
Street address
Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4817818893
Phone
+98 11 3330 2425
Email
t.etezadi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahura Etezadi
Position
assistant professr
Latest degree
Specialist
Other areas of specialty/work
orthodontics
Street address
Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4817818893
Phone
+98 11 3330 2425
Email
t.etezadi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahura Etezadi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
orthodontics
Street address
Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4817818893
Phone
+98 11 3320 2425
Email
t.etezadi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available