The effect of Propolis-containing chewing gum in comparison with Propolis-containing mouthwash on reducing gingival inflammation in patients with gingivitis
Determining the effect of Propolis containing gum in comparison with Propolis containing mouthwash on reducing gingival inflammation in patients with gingivitis referred to Yazd Dental School in the academic year 1401-1400
Design
Clinical trial with 2 intervention groups, parallel group, non-blind, randomized groups using random number table, on 20 patients
Settings and conduct
20 patients aged 18 to 65 years diagnosed with gingivitis among those referred to the periodontics Department of Yazd Dental School and need SRP after oral examination by a dentist will enter the study. Patients are randomly divided in two groups: each group includes 10 patients with gingivitis. One group is given a propolis mouthwash and we asked them to gargle it twice a day for 1 week and the other group is given propolis containing gum and we asked them to use gum 3 times a day after each meal for 20 minutes for 1 week; and at the end we examine the effects of these substances containing propolis on their plaque index, gingival index and papillary bleeding index .
Participants/Inclusion and exclusion criteria
Patients with gingivitis referred to the periodontics Department of Dental School, no systemic diseases, no sensitivity to mouthwash or Propolis containing gum, no smoking, not during pregnancy and lactation, not taking antibiotics, not using other gums during the study and presence of at least 20 teeth (presence of posterior teeth)؛ No-cooperation in the use of mouthwash or Propolis containing gum
Intervention groups
Patients are examined in two groups: each group includes 10 patients with gingivitis. One group is given a propolis mouthwash and the other group is given propolis containing gum and at the end we examine the effects of these substances containing propolis on their gingivitis.
Main outcome variables
plaque index؛ gingival index؛ papillary bleeding index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220420054592N1
Registration date:2022-06-11, 1401/03/21
Registration timing:registered_while_recruiting
Last update:2022-06-11, 1401/03/21
Update count:0
Registration date
2022-06-11, 1401/03/21
Registrant information
Name
Arezou Khabazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
a.khabazian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Propolis-containing chewing gum in comparison with Propolis-containing mouthwash on reducing gingival inflammation in patients with gingivitis
Public title
The effect of Propolis-containing chewing gum in comparison with Propolis-containing mouthwash on reducing gingival inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gingivitis referred to the periodontics Department of Dental School
no systemic diseases
no sensitivity to mouthwash or Propolis containing gum
no smoking
not during pregnancy and lactation
not taking antibiotics
not using other gums during the study
presence of at least 20 teeth (presence of posterior teeth)
Exclusion criteria:
No-cooperation in the use of mouthwash or chewing Propolis containing gum
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Yazd University of Medical Sciences
Street address
School of dentistry, Imam Reza blvd., Imam street, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.015
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque index
Timepoint
In the first session and 7 days after using Propolis
Method of measurement
O’Leary index and a detector tablet
2
Description
Gingival index
Timepoint
In the first session and 7 days after using Propolis
Method of measurement
A probe and the principles of the gingival index system specified by Loe
3
Description
Papillary bleeding index
Timepoint
In the first session and 7 days after using Propolis
Method of measurement
A probe and record the bleeding points around each tooth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Propolis mouthwash, 30% extract, gargle with Propolis mouthwash (produced by Soren Tak Toos Company of Mashhad) twice a day for 1 minute each time at home for 1 week. We ask them not to eat or drink for 30 minutes after using mouthwash.
Category
Treatment - Drugs
2
Description
Intervention group: Propolis gum, Natural gum base, Xylitol, Maltitol, Mannitol, Glycerine, Lecithin,Propolis, use Propolis gum (a product of Saqez manufacturing company Kurdistan (van) Sanandaj ) at home 3 times a day after each meal for 20 minutes (a total of 1 hour a day) for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Dental School
Full name of responsible person
Arezoo Khabazian
Street address
School of dentistry, Imam Reza blvd., Imam street, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Hooshang Mehrparvar
Street address
Central Department ofShahid Sadouhhi University of Medical Science , Bahonar Blve, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2150
Email
Ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Hosein Tabatabaei
Street address
Emam Reza Ave, Dahe Fajr Blvd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0373
Email
Taba48971@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Imam Reza blvd., Imam street, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Imam Reza blvd., Imam street, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Imam Reza blvd., Imam street, Yazd
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Email
arezookhabazian@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
اطلاعات بیشتری وجود ندارد
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