Determining the effect of turmeric mouthwash on gingivitis and dental plaque in comparison with chlorhexidine mouthwash and control group in patients referred to the periodontics department of Islamic Azad School of Dentistry in Tehran in 2021
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 51 patients.
Settings and conduct
All steps are performed by 11th and 12th semester students and Tehran Azad School of Dentistry. Blinding is done by coating on clinical caregivers. After entering the study, each candidate randomly and secretly selected the envelope in a package that contains the mouthwash to be tested with a specific code, each code has already been given to a mouthwash. The process of checking the desired indicators and then scaling is done by a trained person who does not know the type of mouthwash used by the patient. After using the mouthwash, it is referred again in the specified period and the desired indicators are measured.
Participants/Inclusion and exclusion criteria
Admission requirements include: Participants with gingivitis and Bleeding on probing(BOP) > 10%, with dental plaque and between 20 to 40 years of age. Non-entry conditions include: pregnant women, people who have had periodontal treatment in the last 6 months, patients treated with systemic antibiotics, smokers with a history of allergies to turmeric.
Intervention groups
Curcumin mouthwash: After scaling, 10ml of turmeric mouthwash is used 10 minutes after brushing and for 30 seconds. For 14 days and 2 times a day. Chlorhexidine mouthwash: After scaling, 10ml of chlorhexidine mouthwash is used 10 minutes after brushing and for 30 seconds. For 14 days and 2 times a day. Control group: only scaling is done and no mouthwash is used.
Main outcome variables
Type of mouthwash used and its effect on dental plaque and gingivitis inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040460N8
Registration date:2021-04-10, 1400/01/21
Registration timing:registered_while_recruiting
Last update:2021-04-10, 1400/01/21
Update count:0
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-10, 1400/01/21
Expected recruitment end date
2021-06-04, 1400/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin mouthwash on the indicators of gingivitis and dental plaque in patients referred to the School of Dentistry
Public title
The effect of curcumin mouthwash on the indicators of gingivitis and dental plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20>Age>40
Dental plaque
Bleeding on probing>10%
Gingivitis
Exclusion criteria:
Pregnant women
People who have had periodontal treatment in the last 6 months
History of curcumin sensitivity
Tobacco consumers
Patients treated with systemic antibiotics
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with generalized gingivitis are selected and included in the study. Patients are randomized in a block, so that packages consisting of 9 papers consisting of 3 papers from each group (3 to chlorhexidine, 3 to curcumin and 3 to control) are placed in front of the patient and the patient selects one of them randomly and enters that group, and after the completion of these 9 patients, the next patients (next 9 people) enter the study so that the process of getting sick can proceed simultaneously in all 3 groups. Next, the process of scaling and reviewing the indicators is done by a trained person who does not know what group the patient is in, so as not to be biased.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers and outcome assessors have no idea which groups the participants will be studied in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Medical Sciences
Street address
Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-01-08, 1399/10/19
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.159
Health conditions studied
1
Description of health condition studied
Gingival inflammation and dental plaque
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Dental plaque: Determining the amount of dental plaque is evaluated based on the TURESKY index and is measured after using the disclosure pill and is expressed between 0-5 according to the presence or absence of plaque. Gingivitis: Based on the bleeding areas and based on the Modified Sulcular bleeding index is measured with a periodontal probe and is expressed between 0-3 depending on the presence or absence of bleeding.
Timepoint
Day 0 and day 14
Method of measurement
Dental plaque: Determining the amount of dental plaque is evaluated based on the TURESKY index and is measured after using the disclosure pill and is expressed between 0-5 according to the presence or absence of plaque. Gingivitis: Based on the bleeding areas and based on the Modified Sulcular bleeding index is measured with a periodontal probe and is expressed between 0-3 depending on the presence or absence of bleeding.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients who do not use any mouthwash and the desired indicators (plaque and gingivitis) are measured on the first day and then scaling and after 14 days the indicators are checked again.
Category
Treatment - Other
2
Description
First intervention group: Patients who are initially scaled and after measuring the indicators for 14 days use Najo chlorhexidine mouthwash for 0.2% and the indicators are evaluated 14 more times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash.
Category
Treatment - Other
3
Description
Second Intervention group : Patients who are initially scaled and after measuring the indicators for 14 days use curcumin mouthwash 0.2% of Sina Curcumin company and the indicators are evaluated 14 times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Tehran Azad University of Medical Sciences
Full name of responsible person
Dr. Nima Naddafpour
Street address
Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
nima.na04@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
nima.na04@gmail.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
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
Islamic Azad University
Full name of responsible person
Seyed Navid Mirazimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 1, Fifth Narenjestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1957917711
Phone
+98 21 2282 6301
Email
navidmirazimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Nima Naddafpour
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Neyestan 9 Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
nima.na04@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Navid Mirazimi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 1, Fifth Narenjestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1957917711
Phone
+98 21 2282 6301
Email
navidmirazimi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD