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Evaluation of Clinical Effect of Hydroalcoholic Extract of Whole Pomegranate Fruit on Dental Plaque Formation in 8-10-Year-Old Children

Protocol summary

Study aim
Evaluation of the Clinical Effect of Pomegranate Mouthwash on Plaque Formation in 8-10 year Old Children.
Design
This Clinical Study is Conducted on 14 Children aged 8-10 years in a Cross-over Design, and based on a Random Table, they receive 38% Pomegranate Mouthwash and 0.12% Chlorhexidine.
Settings and conduct
In the First Meeting, Prophylaxy is performed for all Participants in the Pediatric Department of Tehran Islamic Azad Dental School and After 2 Days of Lack of Hygiene, A PI is Recorded, and the First Mouthwash is consumed for 2 Days and the PI is Recorded, and After a Week of wash out, the order of using the Second Mouthwash Begins. Plaque Evaluation is performed by a Pediatric Dental Specialist who is not Aware of the Study Groups, and the Participants receive Mouthwashes with and without Frames.
Participants/Inclusion and exclusion criteria
Systemic Health, No Antibiotic Intake within the Past 3 Weeks Prior to the Study Onset, Absence of Oral Habits, No Use of Orthodontic Or Prosthetic Appliances, No Zerostomia, No Periodontal Disease, and Absence of Active Caries in the Buccal and Lingual Surfaces of Maxillary Right First Molar, Mandibular Left First Molar, Maxillary Left Lateral Incisor, Mandibular Right Lateral Incisor, Maxillary Right Central Incisor, and Mandibular Left Central Incisor.
Intervention groups
Participants will receive 38% Pomegranate Mouthwash and 0.12% Chlorhexidine Mouthwash in a Crossover Design.
Main outcome variables
The Amount of Dental Plaque

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230110057104N1
Registration date: 2023-02-17, 1401/11/28
Registration timing: registered_while_recruiting

Last update: 2023-02-17, 1401/11/28
Update count: 0
Registration date
2023-02-17, 1401/11/28
Registrant information
Name
Mandana Alamdari mahd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 4299
Email address
m.alamdari@student.iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2023-02-25, 1401/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clinical Effect of Hydroalcoholic Extract of Whole Pomegranate Fruit on Dental Plaque Formation in 8-10-Year-Old Children
Public title
Evaluation of Effect of Hydroalcoholic Pomegranate Extract on Plaque Formation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Systemic Health No Antibiotic Intake within the Past 3 Weeks Prior to the Study Onset Absence of Oral Habits No Use of Orthodontic or Prosthetic Appliances No Xerostomia No Periodontal disease, and Absence of Active Caries in the Buccal and Lingual Surfaces of Maxillary Right First Molar, Mandibular Left First Molar, Maxillary Left Lateral Incisor, Mandibular Right lateral Incisor, Maxillary Right Central Incisor, and Mandibular Left Central Incisor. Age 8-10 years
Exclusion criteria:
Lack of cooperation to use mouthwash Taking another mouthwash now Allergy to mouthwash ingredients Not paying attention to the instructions during the study, including not using gum and not brushing teeth in 48 hours
Age
From 8 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
This cross-over study includes two treatments A (framed mouthwash) and B (unframed mouthwash) and people are placed in AB and BA groups in a simple random manner using a table of random numbers with the help of Rand option of Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two mouthwashes are completely identical in terms of the bottle, color, and by adding flavoring, and the mouthwashes are given to the participant in framed and unframed form with the indication of how to use them. Plaque evaluation and data collection is done by a pediatric specialist who is not aware of the studied groups.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry, Tehran Islamic Azad University of Medical Sciences
Street address
No 11, Yas Ave, Sohanak,Tehran
City
Tehran
Province
Tehran
Postal code
1955819973
Approval date
2023-02-04, 1401/11/15
Ethics committee reference number
IR.IAU.PS.REC.1401.424

Health conditions studied

1

Description of health condition studied
The effect of Mouthwash on the Formation of Microbial Plaque
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
The Amount of Dental Plaque Formation
Timepoint
3,5,14
Method of measurement
Dental Plaque Disclosing Tablets

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:10 mL of the Hydroalcoholic Pomegranate mouthwash rinse twice a day and then spit it out for 2 days.
Category
Prevention

2

Description
Control group: 10 mL of the chlorhexidine mouthwash rinse twice a day and then spit it out for 2 days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Mandana Alamdari Mahd
Street address
No 11, Yas Ave, Sohani Ave,Tehran
City
Tehran
Province
Tehran
Postal code
1955819973
Phone
+98 21 2247 4299
Email
alamdarimandana@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Khoshdel
Street address
Tehran Islamic Azad University of Medical Sciences, Shariati St, Aine Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
alamdarimandana@yahoo.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
Sara Tavassoli Hojati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 10, Karimi Ave, Yarmohamadi Ave, darus,Tehran
City
Tehran
Province
Tehran
Postal code
1955819973
Phone
+98 21 2255 9108
Email
tavasolisara@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Tavassoli Hojati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 10, Karimi Ave, Yarmohamadi Ave, darus,Tehran
City
Tehran
Province
Tehran
Postal code
1955819973
Phone
+98 21 2255 9108
Email
tavasolisara@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Alamdari mahd
Position
Padiatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 11,Yas alley,Sohani Ave,Artesh Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1955819973
Phone
+98 21 2247 4299
Fax
Email
alamdarimandana@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
Participants do not wish to share their information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information related to the outcome of the study and the study protocol will be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers who have a research plan in this field.
Under which criteria data/document could be used
If the information is preserved.
From where data/document is obtainable
alamdarimandana@yahoo.com
What processes are involved for a request to access data/document
Send a Message to the said Email, if Similar Research Work is done in this Field, Sufficient Information Regarding the Results and Study Protocol will be Emailed.
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