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Comparison of nanocurcumin and chlorhexidine mouthwash on levels of gingival crevicular fluid interleukin 1 and 6 in patients undergoing fixed orthodontics treatment

Protocol summary

Study aim
Comparison of nanocurcumin and chlorhexidine mouthwash on levels of gingival crevicular fluid interleukin 1 and 6 in patients undergoing fixed orthodontics treatment
Design
Single blind clinical trial on patients undergoing randomized block orthodontic treatment in four groups (using a mouthwash containing curcumin nanoparticles, using a chlorhexidine mouthwash and a group using two nanocurcumin and chlorhexidine mouthwashes and the control group)
Settings and conduct
Orthodontics Department, Dental School, Golestan University of Medical Sciences
Participants/Inclusion and exclusion criteria
The subjects’ inclusion was based on the following criteria: agreement to participation in the current study, 15 to 35 years old, exhibit good periodontal health, systemically healthy, passed at least 2 mounts after fixed orthodontics treatment, negative for hypersensitivity to curcumin and/or chlorhexidine. Participants who used tobacco, who had used antibiotics, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) during the past one month, and pregnant and lactating mothers were excluded from this study.
Intervention groups
nanocurcumin and chlorhexidine mouthwash application
Main outcome variables
interleukin 1 and 6 levels in gingival crevicular fluid

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220223054108N1
Registration date: 2022-04-03, 1401/01/14
Registration timing: prospective

Last update: 2022-04-03, 1401/01/14
Update count: 0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Aliakbar Naghavialhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3262 7823
Email address
a.a.nagavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2023-03-05, 1401/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nanocurcumin and chlorhexidine mouthwash on levels of gingival crevicular fluid interleukin 1 and 6 in patients undergoing fixed orthodontics treatment
Public title
Effects of nanocurcumin and chlorhexidine mouthwash on levels of interleukin 1 and 6
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Agreement to participation in the current study 15 to 35 years old Good periodontal health Systemically healthy Passed at least 2 mounts after fixed orthodontics treatment Negative for hypersensitivity to Curcumin and/or chlorhexidine.
Exclusion criteria:
Tobacco usage Antibiotics, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) usage during the past one month Pregnant and lactating mothers
Age
From 15 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subjects will be assigned to the nanocurcumin and chlorhexidine mouthwash groups, the nanocurcumin only and chlorhexidine only, and the control group using the random block method. We first create a random sequence of 11 eight-block random blocks. In each block, each letter A, B, C, D is repeated twice. ABCDACDB, CADBACBD, DACBBCAD, ABBCDACD, CADBACDB,… In the desired sequence, there will be 22 letters from each letter A, B, C, D. According to the above block, 88 envelopes will be prepared, and in each envelope, the letters A, B, C, D will be placed and will be numbered from 1 to 88. The person delivering the envelopes to the patients does not know what is inside. A random sequence is produced by a statistics and methodology consultant who does not have access to patients, and only he knows what is in each number. Patients who received the letter A in the nanocurcumin and chlorhexidine mouthwash group, patients who received the letter B in the nanocurcumin group, and patients who received the letter C in the chlorhexidine group patients who received the letter D in the control group will be placed.
Blinding (investigator's opinion)
Single blinded
Blinding description
A random sequence is produced by a statistics and methodology consultant who does not have access to patients, and only he knows what is in each number.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Golestan University of Medical Sciences
Street address
Shahryar
City
Gorgan
Province
Golestan
Postal code
4913983635
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.GOUMS.REC.1400.386

Health conditions studied

1

Description of health condition studied
teeth shifting
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Interleukin 1 & 6 before and two weeks later in the patients consuming curcumin mouthwash
Timepoint
Measurement of Interleukin1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA test)

2

Description
Interleukin 1 & 6 before and two weeks later in the group of patients consuming chlorhexidine mouthwash
Timepoint
Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA test)

3

Description
Interleukin 1 & 6 before and two weeks after in the group consuming curcumin + chlorhexidine mouthwash
Timepoint
Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA test)

4

Description
Interleukin 1 & 6 before and two weeks after in the group of patients consuming normal saline mouthwash
Timepoint
Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA test)

Secondary outcomes

1

Description
Comparison of differences in Interleukin 1 & 6 concentration before and two weeks later between two groups of patients using mouthwash containing curcumin and chlorhexidine
Timepoint
before treatment and 2 weeks after starting fixed orthodontic treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)

2

Description
Comparison of difference in Interleukin1 & 6 concentration before and two weeks later between two groups of patients using mouthwash containing curcumin and curcumin + chlorhexidine
Timepoint
before treatment and 2 weeks after starting fixed orthodontic treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)

3

Description
Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing curcumin and normal saline
Timepoint
before treatment and 2 weeks after starting fixed orthodontic treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)

4

Description
Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing chlorhexidine and curcumin+ chlorhexidine
Timepoint
before treatment and 2 weeks after starting fixed orthodontic treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)

5

Description
Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing chlorhexidine and normal saline
Timepoint
before treatment and 2 weeks after starting fixed orthodontic treatment
Method of measurement
ELISA (enzyme-linked immunosorbent assay)

Intervention groups

1

Description
Intervention group 1: In this group, patients are asked to mix 20 drops of nanocurcumin mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing. Dr. Khori Danesh Bonyan Pharmaceutical Company makes Nanocurcumin mouthwash with a concentration of 2% with confirmation code No. 184620 of Golestan University of Medical Sciences. This mouthwash is prepared with the chemical composition C21H20O6 with over 70% purity degree and a molecular weight of 368 from Sigma & Aldrich Co.
Category
Prevention

2

Description
Intervention group 2: In this group, patients are asked to mix 20 drops of 2% chlorhexidine mouthwash with 10 cc of water and use for 30 seconds according to the written instruction on the mouthwash twice a day for two weeks after brushing.
Category
Prevention

3

Description
Intervention group 3: In this group, patients are asked to mix 20 drops of nano-curcumin plus chlorhexidine combined mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing.
Category
Prevention

4

Description
Control group: In this group, patients are asked to use 10 cc of normal saline as a mouthwash for 30 seconds as a mouthwash twice a day for two weeks after brushing.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontics Department- Dental School- Golestan University of Medical Sciences
Full name of responsible person
Aliakbar Naghavialhosseini
Street address
Shahryar 5 St.، Shahryar Town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 911 171 6706
Email
a.a.nagavi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Vahid Khori
Street address
Edalat 31 St., Naharkhoran Ave.
City
Gorgan
Province
Golestan
Postal code
4916766176
Phone
+98 17 3233 0700
Email
vaph99@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
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
Gorgan University of Medical Sciences
Full name of responsible person
Aliakbar Naghavialhosseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar 5 St., Shahryar Town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 7823
Email
a.a.nagavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Aliakbar Naghavialhosseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar 5 St., Shahryar Town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 7823
Email
a.a.nagavi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Aliakbar Naghavialhosseini
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahryar 5 St., Shahryar Town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 7823
Email
a.a.nagavi@gmail.com

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
Not applicable
Data Dictionary
Not applicable
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