Protocol summary
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Study aim
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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
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Design
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Clinical Trial with Two Intervention Groups, with parallel groups, blinded, randomised, 70 patients
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Satisfaction Rate, Plaque Index, Gingival Index
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210605051494N1
Registration date:
2021-07-11, 1400/04/20
Registration timing:
prospective
Last update:
2021-07-15, 1400/04/24
Update count:
1
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Registration date
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2021-07-11, 1400/04/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-16, 1400/04/25
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Expected recruitment end date
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2021-08-16, 1400/05/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-08, 1400/03/18
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Ethics committee reference number
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IR.MUQ.REC.1400.050
Health conditions studied
1
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Description of health condition studied
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Plaque Index and Gingival Index
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Plaque Index and Gingival Index
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Timepoint
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Measurement of Plaque Index and Gingival Index before Using Toothpaste (after scaling and Root Planning and Brusage) and 14 Days after Using Toothpaste
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Method of measurement
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Fuchsin tablet and periodontal probe
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Assistant of Qom University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more Information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available