The aims of this study are determining the Effective Concentration of Thymus Vulgaris essential oil on Candidate Albicans and Use of Zataria Multiflora essential oil as an Herbal Disinfectant during the Treatment of Orthodontic as Replacement of Chlorhexidine
Design
Randomized control trial, Two parallel group, double blinded,
Settings and conduct
The study were conducted in private office of one of the researchers in Shiraz. Each group used one of the two solutions, Thymus vulgaris and Chlorhexidine, for one week . After using the following solution, swabs were taken from three points of orthodontic appliance. Patients and researchers who delivering solutions and swabs were blind in this study.
Participants/Inclusion and exclusion criteria
Exclusion criteria:
Moderate to Severe Crowding and Irregularity
Periodontal Problem
Usage of Antimicrobial Mouth Watch
Antibiotic therapy within 90 days
poor oral hygiene
History of rheumatic fever, History of diabetes, hepatic, renal and immune system disease
Inclusion criteria:
patients aged 7 to 12 with expansion orthodontic appliance.
Intervention groups
At the beginning of the study, the participants with removable orthodontic applaince infected with candida albicans which had been detected by Laboratory sampling, are divided into intervention and control groups. Intervention group obtained a solution containing Thymus Vulgaris and control group containing chlorhexidine. They were asked to spray solutions on to an orthodontic removable appliance. Swab from three specific of removable orthodontic appliance were taken three times:
1. At the beginning of study
2. After two days
3. After 5 five days
Main outcome variables
The antifungal effect of Thymus Vulgaris on Candida albicans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041092N1
Registration date:2019-11-23, 1398/09/02
Registration timing:retrospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Tahereh Baherimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 1516
Email address
t_baheri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
2019-04-20, 1398/01/31
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-08-28, 1398/06/06
Scientific title
Clinical comparison of the effect of Thymus Vulgaris essential oil and Chlorhexidine on Candida albicans accumulated on orthodontic removable plaques
Public title
effect of Thymus Vulgaris essential oil on Candida albicans
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with expansion orthodontic appliance
Exclusion criteria:
Moderate to Severe Crowding and Irregularity
Periodontal Problem
Usage of Antimicrobial Mouth Watch
Antibiotic therapy within 90 days
poor oral hygiene
History of rheumatic fever, History of diabetes, hepatic, renal and immune system disease
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and all researchers except that person who determines code to the solutions are blind in this study.
Only one researcher who determines color code to the solutions, does not play a role in collecting data is not blind in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad University of Shiraz
Street address
School of Dentistry, Shiraz Azad University, North ghaani Ave.
City
Shiraz
Province
Fars
Postal code
71993-5
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1397.004
Health conditions studied
1
Description of health condition studied
In the present study, to find the desired sample size, a number of patients with removable orthodontic plaque in a private clinic were randomly selected. Before starting the study, an interview was conducted with them to evaluate their dental and medical history, oral health status, occlusion and proper dental care and their health status. Of the 43 patients who were sampled, those who had one of the following were excluded from the study, and 36 who were eligible for inclusion in the study were selected for further studies: - No Candida albicans on Orthodontic removable plaque-Large diastema-Periodontal problem-Use Antimicrobial mouthwash-Antibiotic use in the last 3 months-Very poor oral hygiene
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people with Candida albicans on orthodontic removable plaque and Clinical comparison of the effect of Zataria Multiflora essential oil and Chlorhexidine on Candida albicans accumulated on orthodontic removable plaques.
Timepoint
Sampling and Count of Candida albicans colonies at the beginning of the study (before intervention), 2 and 5 days after spraying with 2%Zataria Multiflora essential oil and chlorhexidine.
Intervention group: Participants in intervention group obtained a solution containing thymus vulgaris 2%. They were asked to spray solutions on to an orthodontic removable appliance.Swab from three specific of removable orthodontic appliance were taken three times: 1.At the beginning of study. 2. After two days. 3. After 5 five days.
Category
Treatment - Drugs
2
Description
Control group: Participants in control group obtained a solution containing Chlorhexidine 0/2%. They were asked to spray solutions on to an orthodontic removable appliance. Swab from three specific of removable orthodontic appliance were taken three times:1. At the beginning of study2. After two days3. After 5 five days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Shiraz Azad University
Full name of responsible person
Tahereh Baherimoghadam
Street address
3th Floor , medical Bldg. 11 Alley, Sattarkhan Ave.
City
Shiraz
Province
Fars
Postal code
71847-35716
Phone
+98 71 3649 1415
Email
T_baheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Baheri
Street address
3th Floor , medical Bldg. 11 Alley, Sattarkhan Ave.
City
Shiraz
Province
Fars
Postal code
71847-35716
Phone
+98 71 3649 1415
Email
T_baheri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Tahereh Baheri Moghadam
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3th Floor, medical Bldg, 11 Alley, Sattar Khan Ave.
City
Shiraz
Province
Fars
Postal code
71847-35716
Phone
+98 71 3649 1415
Email
T_baheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Navid Naseri
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3th floor, medical Bldg, 11 Alley, Sattar Khan Ave.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Classification of individuals based on the number of Candida albicans grown colonies in three sampling times (Before spraying 2% Thymus Vulgaris essential oil and Chlorhexidine 0.2%, two days and then five days after spraying)
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Every one
Under which criteria data/document could be used
No one is allowed to work on our data
From where data/document is obtainable
send Email to T-baheri@yahoo.com and announce the request.
What processes are involved for a request to access data/document
send Email to T-baheri@yahoo.com and announce the request.