Evaluation the effect of mouth wash contains punica granatum extract in comparison with chlorhexidine mouth wash on improvement of periodontal index in chronic mild to moderate periodontitis
Evaluation the effect of mouth wash contains punica granatum extract in comparison with chlorhexidine mouth wash on improvement of periodontal index in mild to moderate chronic periodontitis.
Design
non randomized double blind clinical trial with control group, parallel groups, third phase on 30 patients.
Settings and conduct
It will be performed at the periodontolgy department of Alborz Dental University.executor, clinical caregiver, data analyzer, outcome assessor, the person under study and data analyzer are blinded.
people with all the inclusion criteria are selected and then all the required information is provided to them and if they are satisfied date of first session will be fixed.
Participants/Inclusion and exclusion criteria
"inclusion criteria":not smoker؛ not alcohol consumer؛ no antibiotic intake؛ not pregnant؛ no history of allergic reaction؛ no systematic diseas؛ not in breast feeding period؛ has mild to moderate chronic periodontitis.
they should have mild to moderate periodontitis.
Intervention groups
"Intervention group:" Ultrasonic scaling is performed as the first line of treatment for patients with mild to moderate periodontitis.
The patient will use mouthwash for two weeks that containing 2% punica granatum extract which produced in the Faculty of Pharmacy of Alborz University of Medical Sciences twice a day and 1 minute each time.
1 month and 3 months after scaling, he refers to check and re-measure gingival indices.
"Control group:" completely identical to the intervention group, only mouthwash is replaced with 0.2% chlorhexidine from NAJO company.
Evaluation the effect of mouth wash contains punica granatum extract in comparison with chlorhexidine mouth wash on improvement of periodontal index in chronic mild to moderate periodontitis
Public title
effect of maouthwash contains punica granatum extract on periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
not alcohol consumer
non smoker
not pregnant
no antibiotic usage
no allergic reaction
not breastfeeding
no systematic disease
mild to moderate chronic periodontitis
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. This method is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and in this two-group experiment, we will have 4 blocks of 8 (including 4 people participating in the intervention group and 4 people participating in the control group), Due to the possibility of people not attending the follow-up sessions, 2 people are considered more than the sample size. The site https://www.sealedenvelope.com/simple has been used for random assignment of individuals to groups.
In this method we use sealed envelopes with a random sequence. Each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes open in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The codes for each group will be kept in a closed envelope. After the person is eligible to enter the study, based on the obtained sequence, one of the two interventions will be performed for him. The solutions are in the same jars and are similar in color and size, and no one untill the end of the study, when the research report is being prepared, neither the researcher, nor the assistant, nor the participant has any knowledge that labels A or B belong to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Katooei st, Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198684868
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.ABZUMS.REC.1399.256
Health conditions studied
1
Description of health condition studied
Chronic mild to moderate periodontitis.
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
periodontal pocket depth
Timepoint
before intervention, after 1 month, after 3 month
Method of measurement
with WHO periodontal probe
2
Description
clinical attachement loss
Timepoint
before intervention, after 1 month, after 3 month
Method of measurement
with WHO periodontal probe
3
Description
gingival index
Timepoint
before intervention, after 1 month, after 3 month
Method of measurement
with WHO periodontal probe
4
Description
bleeding on probing
Timepoint
before intervention, after 1 month, after 3 month
Method of measurement
with WHO periodontal probe
5
Description
bacterial culture
Timepoint
before intervention, after 1 month, after 3 month
Method of measurement
pharmacoupe culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and clinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 2 percent punica granatum extract that produced by Pharmacy Faculty of Alborz University of Medical Sciencestwice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers. Then the results are compared with the results of control group.
Category
Treatment - Other
2
Description
control group: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and the amount ofclinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 0.2 percent chlorhexidine(NAJO) twice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Alborz University of Medical Sciences
Full name of responsible person
Ali Bayat
Street address
Katooei st, Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5110
Email
alibt77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Doctor hatam godini
Street address
Safarian st, Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4083
Fax
+98 26 3464 3705
Email
h.godini@abzums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Ali Bayat
Position
Dental intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Number20, West 5th, Tohid ave,Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1653636411
Phone
+98 21 4465 4507
Email
alibt77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali Bayat
Position
Dental intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Number 20, west 5th, street Tohid ave., Tehranpars, Tehran
City
Tehran
Province
Tehran
Postal code
1653636411
Phone
+98 21 4465 4507
Email
alibt77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Ali bayat
Position
Dental intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Number 20, 5th west street, Tohid ave., Tehran pars Tehran
City
Tehran
Province
Tehran
Postal code
1653636411
Phone
+98 21 4465 4507
Email
alibt77@gmail.com
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