This study was performed to compare the effect of pomegranate mouthwash and chlorhexidine mouthwash on clinical improvement of severe chronic periodontitis.
Design
A randomized controlled clinical trial with factorial groups, double blind, randomized
Settings and conduct
A questionnaire including patient characteristics and inflammatory criteria will be completed by the plan administrator for patients referring to the periosteum department of Zahedan Dental School, where severe chronic periodontitis is diagnosed.
Then there will be a scaling-up phase for patients, whilst simultaneously explaining health education for toothbrushing and dental floss training for all patients.
The patients are then referred to the ward secretary who randomly selects and opens one of the 48 closed envelopes. This choice can be one of the pomegranate skin rinses, pomegranate seeds, saline or chlorhexidine 0.12%. Patients will be told to use mouthwashes or saline 2 times daily for 1 minute to 1 month, during which time they will not use any other medicines, pomegranates, or products containing pomegranate or other mouthwashes. After 2 weeks, 1 month and 3 months the patients will be recalled and the markers will be recorded by the same examiner who did not know the type of mouthwash.
Participants/Inclusion and exclusion criteria
In this study, 48 patients with severe chronic periodontitis were enrolled. Informed consent will be obtained from patients.
Intervention groups
Group A Physiological Serum (Control)
Group B Pomegranate peel mouthwash
Group pomegranate seed mouthwash
Group D Chlorhexidine 0.12% Mouthwash
Main outcome variables
Depth of envelope
SULCUS BLEEDING INDEX
MODIFIED GINGIVAL INDEX
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200203046356N1
Registration date:2020-03-01, 1398/12/11
Registration timing:registered_while_recruiting
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
fatemeh bazzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 3559
Email address
fatemeh.bazzi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluation of the effect of pomegranate mouthrinse and chlorohexidine mouthrinse on severe chronic periodontitis treatment
Public title
The effect of pomegranate mouthwash
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Referred to Zahedan Dental School
No previous treatment of periodontitis
No antibiotic use in the past 6 months
Lack systemic diseases affecting the periodontium
No corticosteroids use
Non-pregnancy and lactation
No smoking
chronic severe periodontitis(clinical attachment loss more than 5 mm) measured by the Williams probe
Exclusion criteria:
If the patient consumes pomegranate or pomegranate products (such as pomegranate juice) or other mouthwash other than as prescribed during the study period, the patient will be excluded.
unwillingness to participate in further study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used and 48 closed envelopes are provided. People randomly select and open one.
Of the 48 envelopes, 12 envelopes will be assigned to each of the A groups of placebo, B of pomegranate skin mouthwash, C of pomegranate seed mouthwash and D of chlorhexidine of 0.12%.
Blinding (investigator's opinion)
Double blinded
Blinding description
The envelopes containing the mouthwash codes are kept with the secretary and the mouthwashes containing physiological serum, pomegranate skin mouthwash and pomegranate seed mouthwash and chlorhexidine mouthwash are packed in similar containers and in groups (A) and (B) And (C) and (D) are named and coded. The codes for each container for the patient are unknown to the researcher and will be kept confidential until the end of the study by the supervisor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-01-26, 1398/11/06
Ethics committee reference number
IR.ZAUMS.REC.1398.382
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Depth of envelope
Timepoint
After 2 weeks, 1 month and 3 months of starting use of mouthwash
Method of measurement
By Williams Probe
2
Description
MODIFIED GINGIVAL INDEX
Timepoint
After 2 weeks, 1 month and 3 months of starting use of mouthwash
Method of measurement
By clinical examination
3
Description
SULCUS BLEEDING INDEX
Timepoint
After 2 weeks, 1 month and 3 months of starting use of mouthwash
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Physiological serum (placebo) is used twice a day for 1 minute to 1 month to wash the mouth.
Category
Placebo
2
Description
Intervention group: Pomegranate peel mouthwash is used twice a day for 1 minute to 1 month to wash mouth.
Category
Treatment - Drugs
3
Description
Intervention group: Pomegranate seed mouthwash is used twice a day for 1 minute to 1 month to wash the mouth.
Category
Treatment - Drugs
4
Description
Intervention group: Chlorhexidine 0.12% mouthwash is used twice a day for 1 minute to 1 month to wash the mouth.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental School Priodontology section
Full name of responsible person
Fatemeh Bazzi
Street address
Eastern Azadegan Ave., Zahedan Dental School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
fatemeh.bazzi@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Bazzi
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
fatemeh.bazzi@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sanaz Isar
Position
B.Sc., Research Expert
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 5705
Fax
+98 54 3241 4003
Email
Arbabi.Parvin@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parvin Arbabi Kalati
Position
Gum surgry Expert
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
Arbabi.Parvin@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Bazzi
Position
دانشجو دندانپزشکی
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Azadegan Shargi St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3244 1814
Fax
+98 54 3241 4003
Email
Fatemeh.bazzi@zaums.ac.ir
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
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