Comparison of the Effectiveness of a Herbal Toothpaste containing Salvadora Persica, Propolis and Stevia with a common Chemical Toothpaste on Improving Plaque Index and Gingival Index in Dental Students
Comparison of the Effectiveness of Herbal Toothpaste Containing Salvadora Persica, Propolis and Stevia with the common Chemical Toothpaste in Iran on Plaque Index and Gingival Index
Design
Clinical Trial with Two Intervention Groups, with parallel groups, blinded, randomised, 70 patients
Settings and conduct
To Determine the Plaque Index, The Fuchsin Tablet is used on all Supragingival Dental Surfaces and The Amount of Plaque on the Buccal and Lingual Surfaces of all Teeth except the Third Molars will be evaluated.
LÖe & sillnes sillnes Index is used to Measure the Gingival Index.
Study place: Periodontology department of Qom Dental School
Participants/Inclusion and exclusion criteria
Entry Requirements: Normal Periodontium - No Systemic Diseases - No History of Antibiotics and Anti-Inflammatory Drugs and Periodontal Treatment in the Last 3 Months - Age 18 Years and Older - Having at least 20 Teeth in the Mouth
Exit conditions: Orthodontic Appliance - Fixed or Removable Dental Prosthetics - Smokers - Pregnant or Breastfeeding People - People with Definite Allergies to Herbal Ingredients in Herbal Toothpaste
Intervention groups
People are divided into Two Intervention Groups 1 and 2. In both Groups, Scaling and Root Planning and Brusage are performed first, And then Plaque and Gingival Indexes are measured. Then One Group is given Herbal Toothpaste and the other Group is given Chemical Toothpaste. People use their Toothpaste for 14 Days and then the Plaque and Gingival Indexes are measured Again.
Main outcome variables
Satisfaction Rate, Periodontal Index, Plaque Index, Gingival Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210605051494N1
Registration date:2021-07-11, 1400/04/20
Registration timing:prospective
Last update:2021-07-11, 1400/04/20
Update count:1
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Mahdi Dolatkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5520 9664
Email address
dolatkhanimahdi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-16, 1400/04/25
Expected recruitment end date
2021-08-16, 1400/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of a Herbal Toothpaste containing Salvadora Persica, Propolis and Stevia with a common Chemical Toothpaste on Improving Plaque Index and Gingival Index in Dental Students
Public title
Comparison of the Effectiveness of a Herbal Toothpaste containing Salvadora Persica, Propolis and Stevia with a common Chemical Toothpaste on Plaque Index and Gingival Index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Normal Periodontium
Absence of Systemic Disease
No history of Antibiotics, Anti-Inflammatory Drugs and Periodontal Treatments in the last 3 months
Age 18 years and Above
Having at least 20 Teeth in the Mouth
Exclusion criteria:
Orthodontic Appliance or Fixed and Removable dental Prosthetics
Smokers
Pregnant and Breastfeeding People
People with definite Allergies to Herbal Ingredients in Herbal Toothpaste
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in two Groups by Block Randomization Method. The Size of the Blocks is 4. The Random Order of the Blocks is also done by Throwing Dice from 6 possible Combinations.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this Study, both Patients and Researchers are kept Blind. To Blind Patients, two similar Tubes with the same Color and Taste content are used. In order to Blind the Researcher, The Research Team sticks Labels A and B on the Tubes and The Therapist is Unaware of the Type of Treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Measurement of Plaque Index and Gingival Index before Using Toothpaste (after scaling and Root Planning and Brusage) and 14 Days after Using Toothpaste
Method of measurement
Fuchsin tablet and periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In This Group, After Scaling and Root Planning and Brusage, the Plaque Index and Gingival Index is Measured First. The Herbal Toothpaste Containing Salvadora Persica, Propolis and Stevia is then given to the Patients. After 14 Days of Using Toothpaste, Plaque and Gingival Index is Measured Again.
Category
Prevention
2
Description
Intervention group: In This Group, After Scaling and Root Planning and Brusage, the Plaque Index and Gingival Index is Measured First. The Common Chemical Toothpaste in Iran is then given to the Patients. After 14 Days of Using Toothpaste, Plaque and Gingival Index is Measured Again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Dental College
Full name of responsible person
Mahdi Dolatkhani
Street address
Qom Dental College, Saheli St., Qom
City
Qom
Province
Ghoum
Postal code
3936737136
Phone
+98 25 3770 3738
Email
Dens@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Dolatkhani
Street address
Qom Dental College, Saheli St., Qom
City
Qom
Province
Ghoum
Postal code
3936737136
Phone
+98 25 3770 3738
Email
Dens@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Dolatkhani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 44, Yadegar Emam St., Rey Town
City
Rey
Province
Tehran
Postal code
1814174795
Phone
+98 21 5522 3660
Email
dolatkhanimahdi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Dolatkhani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 44, Yadegar Emam St., Rey Town
City
Rey
Province
Tehran
Postal code
1814174795
Phone
+98 21 5522 3660
Email
dolatkhanimahdi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mahdi Dolatkhani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 44, Yadegar Emam St., Rey Town
City
Rey
Province
Tehran
Postal code
1814174795
Phone
+98 21 5522 3660
Email
dolatkhanimahdi@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