Determination of the effect of mouthwash containing Propolis on plaque, gingival and periodontal indices in patients with chronic gingivitis
Design
According to the random numbers table, patients who are eligible for inclusion in the study are randomly divided into two groups of 20. All types of mouthwashes are placed in the same glass and encoded in such a way that the patient and the host of the design will not be aware of it.
Settings and conduct
The place of study is at Mashhad University of Medical Science.
Two groups of 20 who took Group 1 Propolis mouthwash and Group 2 Chlorhexidine mouthwash, and plaque, gingival and periodontal indices were administered on that time, two weeks later, three weeks later and four weeks later.
The results will be recorded by someone else based on the given codes and will be Blind. Study is Clinical trial Double-Blinded how the Investigator, participant and outcome assessor are Blind, and is described to patients who receive one of the Chlorhexidine or Propolis mouthwashes.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Have Public Health
No Need Prophylaxis
Not Using Anti Inflammation Within Six Weeks and at the Time of Review
Not Using Drugs like Antihistamine, antidepressant or Analgesic Within Six Weeks and at the Time of Review
No Attachment Loss
Not Pregnant
Exclusion criteria :
Pregnancy or Breastfeeding
Tobacco use
Systemic disease
Unwillingness or patient cooperation
Receive antibiotics over the past 2 weeks
History of using mouthwash in a recent month
Patients with a history of allergy to honey and wax compounds
Intervention groups
Propolis and Chlorhexidine mouthwash
Main outcome variables
Gingival index(GI) , plaque index (PI) and Periodontal index (CPI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039880N1
Registration date:2018-07-05, 1397/04/14
Registration timing:prospective
Last update:2018-07-05, 1397/04/14
Update count:0
Registration date
2018-07-05, 1397/04/14
Registrant information
Name
Amirali Fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 9626
Email address
fazeliaa911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Propolis and Chlorhexidine Mouthwash on Gingival Inflammation in Chronic Gingivitis
Public title
Comparison of the Effectiveness of Propolis and Chlorhexidine Mouthwash on Gingival Inflammation in Chronic Gingivitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have Public Health
No Need Prophylaxis
Not Using Anti Inflammation Within Six Weeks and at the Time of Review
Not Using Drugs like Antihistamine, antidepressant or Analgesic Within Six Weeks and at the Time of Review
No Attachment Loss
Not Pregnant
Exclusion criteria:
Pregnancy or Breastfeeding
Tobacco use
Systemic disease
Unwillingness or patient cooperation
Receive antibiotics over the past 2 weeks
History of using mouthwash in a recent month
Patients with a history of allergy to honey and wax compounds
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
20
receiver of Propolis Mouthwash and Chlorhexidine Mouthwash
Randomization (investigator's opinion)
Randomized
Randomization description
table of random numbers.
All types of mouthwashes are placed in the same glass and encoded in such a way that the patient and the host of the design will not be aware of it.
The results will be recorded by someone else based on the given codes and will be Blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
All types of mouthwashes are placed in the same glass and encoded in such a way that the patient and the host of the design will not be aware of it.
The results will be recorded by someone else based on the given codes and will be Blind.
Study is Double-Blinded how the Investigator, participant and outcome assessor are Blind, and is described to patients who receive one of the Chlorhexidine or Propolis mouthwashes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Park Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.mums.sd.REC.1394.244
Health conditions studied
1
Description of health condition studied
Chronic Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Gingival index (GI) and Plaque index (PI) and Community Periodontal index (CPI)
Timepoint
At the beginning of the study (before the intervention), two weeks, three weeks and four weeks after the intervention began
Method of measurement
universal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Propolis mouthwash. The chemical composition of Propolis is very complex, depending on the species of bee, the type of plant origin and the climate of the corresponding geographical area. Propolis contains wax (most of it), gum and resin, pollen and active ingredients (minerals and vitamins). The Participant is asked to use mouthwash twice a day after the toothbrush for ten days. The patient should hold 15 cc mouthwashes every time for a minute and then abstain from eating and drinking for 30 minutes and not using another mouthwash during the study period.
Category
Treatment - Drugs
2
Description
Control group: chlorhexidine mouthwash 0.12% The Participant is asked to use mouthwash twice a day after the toothbrush for ten days. The patient should hold 15 cc mouthwashes every time for a minute and then abstain from eating and drinking for 30 minutes and not using another mouthwash during the study period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Science
Full name of responsible person
Amirali Fazeli
Street address
Park square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 1882 9501
Fax
Email
fazeliaa911@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majidreza Mokhtari
Street address
Park square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 1882 9501
Email
fazeliaa911@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirali Fazeli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Park square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 1882 9501
Email
fazeliaa911@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirali Fazeli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Park square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 1882 9501
Email
fazeliaa911@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirali Fazeli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Park square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 1882 9501
Email
fazeliaa911@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
available for people working in academic institutions and people working in businesses
Under which criteria data/document could be used
Not required more terms
From where data/document is obtainable
Amirali Fazeli Phone number 00989336957522 e-mial : fazeliaa911@mums.ac.ir
What processes are involved for a request to access data/document
documents /data files are recieved within one week