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Comparison of anti-inflammatory effect of c-Phycocyanin and Chlorhexidine mouthwashes in people with gingivitis; A clinical trial study

Protocol summary

Study aim
Comparison of anti-inflammatory effect of c-Phycocyanin and Chlorhexidine mouthwashes in people with gingivitis
Design
Using random allocation software 2, patients are distributed into two control and intervention groups (each group includes 20 people) using the randomized block method (blocks of 4). The test group received c-Phycocyanin mouthwash and the control group received chlorhexidine mouthwash.
Settings and conduct
The location is in the Periodontology Department of Mazandaran Dental School, explaining all the treatment steps and obtaining a written statement from the patients, measuring clinical parameters including PI, GI and BOP by a final year dental student on Ramfjord teeth, learning oral hygiene to patients, dividing Classification into two test and control groups, delivery of mouthwashes to patients, recording of indicators at the beginning of the study and at the end of the first and third week.
Participants/Inclusion and exclusion criteria
The absence of systemic disease and the presence of gingivitis caused by local stimuli such as plaque and calculusare the entry criteria, and people who have a known allergy to pure compounds from algae, who have not taken antibiotics in the last three months, smokers, pregnant people, and users of effective drugs on the periodontium are excluded from the study.
Intervention groups
In this study, we have two intervention groups ;The test group receives c-Phycocyanin mouthwash and the control group receives chlorhexidine mouthwash (as gold standard). The participants are told to consume 10 ml of the mouthwash twice a day for 1 minute each time, and then not to wash their mouths or eat for an hour. They should do this continuously for 21 days.
Main outcome variables
PI index, GI index, BOP index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240731062605N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: prospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Romina Rabbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 991 869 8587
Email address
rominasunshine79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-03, 1403/06/13
Expected recruitment end date
2025-02-01, 1403/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anti-inflammatory effect of c-Phycocyanin and Chlorhexidine mouthwashes in people with gingivitis; A clinical trial study
Public title
Investigating the effect of phycocyanin mouthwash on gingivitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of systemic disease The presence of gingivitis caused by local irritants such as plaque and calculus
Exclusion criteria:
People who have a known allergy to compounds containing c-Phycocyanin or pure compounds from algae, or who do not want to participate in the study, are excluded from the study. People who have used antibiotics in the last three months Smokers Pregnant women People using drugs that have a specific effect on periodontium, such as anticonvulsants (such as phenytoin, carbamazepine, barbiturate, valproic acid), calcium channel blockers (such as nefidipine, verapamil, diltiazem), immunosuppressive drugs (such as cyclosporine) ) are excluded from the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software 2, patients are distributed into two control and intervention groups (each group includes 20 people) using the randomized block method (blocks of 4). The test group received c-Phycocyanin mouthwash and the control group received chlorhexidine mouthwash (as gold standard)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A clinical trial with a control group with parallel groups, without the possibility of blinding, randomized by random block method, on 40 patients, random allocation software 2 will be used for randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Research Vice-Chancellor _Building No. 2 of the University _Moalem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.MAZUMS.REC.1402.19921

Health conditions studied

1

Description of health condition studied
Gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
Dental plaque index
Timepoint
At the beginning of the study (before using mouthwashes) and 7 and 21 days after starting to use mouthwashes
Method of measurement
Observing and recording the plaque index of each tooth according to the Loe & Silness scale table

Secondary outcomes

1

Description
Gingival index
Timepoint
At the beginning of the study (before using mouthwashes) and 7 and 21 days after starting to use mouthwashes
Method of measurement
Examination and recording of gingival index for each tooth according to Loe & Silness scale table for gingival index

2

Description
Gingival bleeding index
Timepoint
At the beginning of the study (before using mouthwashes) and 7 and 21 days after starting to use mouthwashes
Method of measurement
Examining and recording gingival bleeding for each tooth using a periodontal probe and determining BOP levels in percentage

Intervention groups

1

Description
Intervention group: The test group received c-Phycocyanin mouthwash. The participants are told to consume 10 ml of the mouthwash for 1 minute twice a day, and then not to wash their mouths or eat for an hour. They should do this continuously for 21 days.
Category
Prevention

2

Description
Control group: The control group received chlorhexidine mouthwash (as gold standard). The participants are told to consume 10 ml of the mouthwash for 1 minute twice a day, and then not to wash their mouths or eat for an hour. They should do this continuously for 21 days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Toba dental clinic
Full name of responsible person
Dr.Anahita Ghorbani
Street address
Tubi Dental Clinic, Khazar street , Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
rominasunshine8000@gmail.com
Web page address
https://www.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.pedram Ebrahim nezhad
Street address
Tubi Dental Clinic, Khazar St., Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Email
rominasunshine8000@gmail.com
Web page address
https://www.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
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Position
Specialist in oral and dental diseases
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tubi Clinic, Khazar Street, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
anahita1802@yahoo.com
Web page address
https://www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Anahita Ghorbani
Position
Specialist in oral and dental diseases
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tubi Clinic, Khazar Street, Sari
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 911 151 3085
Email
‏anahita1802@yahoo.com
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Romina Rabbani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Tubi Clinic, Khazar Street, Sari
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 911 681 0081
Email
rominasunshine8000@gmail.com
Web page address
https://www.mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After the completion of the results plan, it will be delivered in the form of a final report and electronically (on a CD) to the Research prasident and Faculty of Dentistry of Mazandaran University of Medical Sciences.
When the data will become available and for how long
The decision regarding the access to the data will be the responsibility of the president of research and the Faculty of Dentistry of Mazandaran Faculty of Medical Sciences, as well as the supervisor.
To whom data/document is available
President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
Under which criteria data/document could be used
To present the final report and write the article
From where data/document is obtainable
President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
What processes are involved for a request to access data/document
A written request to the president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor
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