The effects of sumac (rhus coriaria) mouthwash as adjuvant treatment in patients with gingivitis
Design
l trial has a control group, with parallel groups, double-blind
Settings and conduct
zahedan dental school
Participants/Inclusion and exclusion criteria
Patients with at least 20 teeth
Index of gingival inflammation and gingival bleeding with a minimum code of 13
No smoking
No history of antibiotic use in the past three months
Not using orthodontic devices or removable prosthesis
Willingness to enter the study
No history of sensitivity to various mouthwashes
Not having oral diseases (pemphigus-lichen planus, etc.)
Not using mouthwash according to the protocol
noPregnancy and breastfeeding
no Smoking or opium
no Taking antibiotics, corticosteroids or non-steroidal anti-inflammatory drugs during the study period
no Use of mouthwash in the last three months
no Suffering from acute or chronic dental or periodontal infection and abscess and periodontitis, salivary gland disorders such as Sjogren's, stone, infection, no neoplasm, history of radiotherapy
Intervention groups
Control - placebo user - sumac mouthwash user
Main outcome variables
gingival inflamation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191012045067N9
Registration date:2023-08-24, 1402/06/02
Registration timing:registered_while_recruiting
Last update:2023-08-24, 1402/06/02
Update count:0
Registration date
2023-08-24, 1402/06/02
Registrant information
Name
masoomeh shirzaiy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3321 1135
Email address
shirzaiy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sumac (rhus coriaria) mouthwash effects as a adjuvant treatment in patients with gingivitis
Public title
Evaluation of sumac (rhus coriaria) mouthwash effects as a adjuvant treatment in patients with gingivitis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least 20 teeth
Index of gingival inflammation and gingival bleeding with a minimum code of 13
no smoking
No history of antibiotic use in the past three months
Not using orthodontic appliances or removable prosthesis
Willingness to enter the study
No history of sensitivity to various mouthwashes
Not having oral diseases (pemphigus-lichen planus, etc.)
using mouthwash according to the protocol
no Pregnancy and breastfeeding
no Smoking or opium
no Taking antibiotics, corticosteroids or non-steroidal anti-inflammatory drugs during the study period
no Use of mouthwash in the last three months
no Having an acute or chronic dental or periodontal infection and abscess and periodontitis, salivary gland disorders such as Sjogren's, stone, infection, neoplasm, history of radiotherapy
Exclusion criteria:
Unwillingness to continue cooperation
Age over 30 years
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of participants to studied groups is done by simple randomization method.In this way, the samples of eligible clients are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) that will be randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and analyzer don't know about drugs and placebo also which one is drug and which one is placebo
The participant and analyzer do not know the type of consumables and the consumables are numbered as 1 , 2,3.The substance is given to the participant in a glass with a coding matte lid and the analyzer records information only based on the desired code
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Dental School, Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98176996930
Approval date
2023-06-18, 1402/03/28
Ethics committee reference number
IR.ZAUMS.REC.1402.124
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Inflammation of gingiva
Timepoint
Before using mouthwash and one week after using mouthwash
Method of measurement
bleeding on probing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, a person rinses 15 cc of sumac (combination of 20 cc sumac powder extract and flavoring)mouthwash twice a day every time for 5 minutes for 1 week.
Category
Treatment - Drugs
2
Description
Intervention group 2-normal saline: In this group, the person rinses 15 cc of normal saline mouthwash twice ready a day every time for 5 minutes for 1 week. .
Category
Placebo
3
Description
Intervention group 3 (control) - Chlorhexidine: In this group, a person rinses 15 cc of Chlorhexidine mouthwash (100 cc ready-made bottle)twice a day every time for 5 minutes for 1 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental School
Full name of responsible person
Masoomeh Shirzaiy
Street address
Dental School, Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
shirzaiy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Ansari Moghaddam
Street address
Dental School, Azadegan Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693v
Phone
+98 54 3344 1824
Fax
Email
ma_sarani2000@yahoo.com
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
1
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Azadegan Street ر Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4005
Email
shirzaiy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Azadegan Avenue Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4005
Email
shirzaiy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Azadegan Street-Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4005
Email
shirzaiy@gmail.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