This Clinical Trial Study will be conducted with the aim of Comparing the Anti-inflammatory effect of Melatonin Mouthwash with Chlorhexidine Mouthwash in people with Gingivitis.
Design
A Clinical Trial with Control and Intervention groups, Double-blind, is conducted on 56 patients who are divided into two groups of 28 Patients.
Using random allocation software 2, patients are distributed into two control and intervention groups (each group includes 28 people) using the randomized block method (blocks of 4).
Settings and conduct
In this study, 56 patients referred to the diagnosis department of Sari Dental Faculty, who were diagnosed with Generalized gingivitis (by a specialist in the diagnosis of oral, maxillofacial diseases and a periodontologist), were included in the Enumeration sampling method are studied.
The study is Double blind.
The patients and the Data collector will not know how the Mouthwash is distributed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Inclusion Criteria include absence of systemic disease, absence of smoking, absence of pregnancy and absence of gingivitis caused by local Factors such as plaque and Calculus.
Exclusion criteria:
People who have used antibiotics in the last three months, have a known allergy to compounds containing Melatonin, or have used drugs with a known effect on the periodontium are excluded from the study.
Intervention groups
The Control group is the people who are given Melatonin Mouthwash to find out the Anti-inflammatory properties of Melatonin.
The Intervention group is the people who are given Gold Standard Chlorhexidine Mouthwash in order to check the Effectiveness of Melatonin.
Main outcome variables
Includes GI PI BOP.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230606058391N1
Registration date:2023-06-14, 1402/03/24
Registration timing:prospective
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Anahita Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 4014
Email address
nsfma4678@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Anti-inflammatory Effect of Melatonin and Chlorhexidine mouthwashes in People with Gingivitis
Public title
Comparing the Effects of Melatonin and Chlorhexidine mouthwash in People with Gingivitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically Healthy
No Smoking
Not Pregnant
Absence of Gingivitis Caused by Local Factors Such as Plaque and Calculus
Exclusion criteria:
People who have used Antibiotics in the last three months
Allergy to compounds containing melatonin
People who have used drugs with specific effects on periodontium
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person collecting information will not know how mouthwash is distributed, and Mouthwashes will be available to Patients in dark bottles with the Same Color and Shape as Codes 1, 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Third floor, Mazandaran University of Medical Sciences, Research and Technology Deputy Buildin, Moalem Square
City
sari
Province
Mazandaran
Postal code
4816895475
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.MAZUMS.REC.1402.041
Health conditions studied
1
Description of health condition studied
Gingivities
ICD-10 code
B99.8
ICD-10 code description
Other infectious disease
Primary outcomes
1
Description
Gingival Index Plaque index Bleeding on probing
Timepoint
At the beginning of the study, 7 and 21 days after the start of using the mouthwash
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received 0.2% Melatonin mouthwash. At the same time as mouthwash is given to the patients, they are taught the correct way to brush (Bass) teeth, use dental floss and mouthwash, by the final year student of the project partner. Patients are asked to use 5 ml of mouthwash twice a day for 30 seconds and then not to wash their mouth or eat for an hour. They should do this continuously for 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: The Control group received 0.2% Chlorhexidine mouthwash. At the same time as mouthwash is given to the patients, they are taught the correct way to brush (Bass) teeth, use dental floss and mouthwash, by the final year student of the project partner. Patients are asked to use 5 ml of mouthwash twice a day for 30 seconds and then not to wash their mouth or eat for an hour. They should do this continuously for 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
Full name of responsible person
Dr.Anahita Ghorbani
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4014
Email
nsfma4678@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Pedram Ebrahimnejad
Street address
Mazandaran University of Medical Sciences, Valiasr Blvd., Imam Khomeinei Square
City
Sari
Province
Mazandaran
Postal code
4515733971
Phone
+98 11 3304 4000
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4014
Email
anahita1802@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Anahita Ghorbani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4818611956
Phone
+98 11 3330 0300
Email
anahita1802@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Anahita Ghorbani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tuba clinic, Dr. Beheshti Blvd., Khazar Square
City
Sari
Province
Mazandaran
Postal code
4818611956
Phone
+98 11 3330 0300
Email
anahita1802@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 further information.
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