Protocol summary

Study aim
Determining the Comparing the effect of mouthwash containing curcumin and oral nanocurcumin on gingivitis in patients with chronic gingivitis who referred to Dental School of Shahid Sadoughi
Design
Clinical trial, with parallel, randomized, phase 2 on 30 patients, for randomization, a table of random numbers is used.
Settings and conduct
30 patients with chronic gingivitis referred to Yazd Dental School, randomly divided into three groups of 10 people: Chlorhexidine mouthwash, curcumin mouthwash and oral nanocurcumin capsule. In the first session we calculate the indicators by examining each patient, then all patients will be given the same health education and , scaling is done for all of them by ultrasonic means. After two weeks, we will be recording the indicators again.
Participants/Inclusion and exclusion criteria
not having systemic disease, no simultaneous use of anticoagulants and antiplatelets, age group 25 to 65 years old, insensitivity to turmeric and its compounds, No need for antibiotic prophylaxis, no smoking, no use of anti-inflammatory substances for six weeks before and at the time of examination, no attachment loss and no periodontal treatment in the last six months, no pregnancy or breastfeeding.
Intervention groups
1. Mouthwash containing curcumin made in Yazd Faculty of Pharmacy, In the house, 3 times a day and every 20 drops of mouth rinse 0.06% of curcumin in 10 ml water and rinse for 30 seconds for two weeks. 2. Curcumin nano micelle capsule 80 mg (Sina Curcumin, prepared by ExirNanoSina, Tehran, Iran), Once a day after breakfast they will receive. 3. Chlorhexidine mouthwash, at home, use it twice a day for 1 minute according to the recipe and do not drink and eat for 30 minutes after mouth washing
Main outcome variables
Gingival Index Plaque Index (silness-loe) Papillary Bleeding Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220420054592N2
Registration date: 2024-02-18, 1402/11/29
Registration timing: prospective

Last update: 2024-02-18, 1402/11/29
Update count: 0
Registration date
2024-02-18, 1402/11/29
Registrant information
Name
Arezou Khabazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
a.khabazian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-26, 1402/12/07
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mouthwash containing curcumin and oral nanocurcumin on gingivitis in patients with chronic gingivitis who referred to Dental School of Shahid Sadoughi
Public title
Comparing the effect of mouthwash containing curcumin and oral nanocurcumin on gingivitis in patients with chronic gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic gingivitis referred to the periodontics department of dental school No systemic disease (no history of gallstones or gallstone obstruction, no active gastrointestinal diseases, liver disease or immunosuppressive system) Age group 25 to 65 years old By matching age and gender in each group Insensitivity to turmeric and its compounds based on patient's self-declaration Needless to antibiotic prophylaxis Non-smoking Not using anti-inflammatory drugs for six weeks prior to and at the time of the check-up Lack of attachment loss Lack of periodontal treatment in the past six months Lack of pregnancy or breastfeeding No simultaneous anticoagulant and antiplatelet use
Exclusion criteria:
Lack of patient cooperation Having symptoms of curcumin allergy
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using Random allocation software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Dental School, Imam Reza Blvd., End of Imam Reza St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914815667
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.064

Health conditions studied

1

Description of health condition studied
Gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Gingival Index
Timepoint
In the first session and two weeks after the start of using oral rinses or nanocurcumin capsules depending on the patient group
Method of measurement
A probe and principles of the gingival index system identified by Leo

2

Description
Plaque Index
Timepoint
In the first session and two weeks after the start of using oral rinses or nanocurcumin capsules depending on the patient group
Method of measurement
Plaque Index (silness-loe)

3

Description
Papillary Bleeding Index
Timepoint
In the first session and two weeks after the start of using oral rinses or nanocurcumin capsules depending on the patient group
Method of measurement
A probe and record bleeding points around each tooth

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The curcumin mouthwash group, For two weeks, 20 drops of 0.06% curcumin mouthwash in 10 ml water and rinse for 30 seconds 3 times a day.
Category
Treatment - Drugs

2

Description
Intervention group: Oral Nano-Curcumin, 80 mg Curcumin Nanomicelle Capsule (Sina Curcumin, prepared by ExirNanoSina, Tehran, Iran), Once a day after breakfast.
Category
Treatment - Drugs

3

Description
Intervention group: Chlorhexidine mouthwash, at home, use it twice a day for 1 minute according to the recipe and do not drink and eat for 30 minutes after mouth washing.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Dental School
Full name of responsible person
Arezoo Khabazian
Street address
Dental School, Imam Reza Blvd., End of Imam Reza St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Hooshang Mehrparvar
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2150
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Imam Reza Blvd., End of Imam Reza St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Imam Reza Blvd., End of Imam Reza St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabaian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Imam Reza Blvd., End of Imam Reza St., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.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
There is no more data.
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
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