Evaluation of Toothpaste on Dental Plaque
Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 22, 2023
May 1, 2023
8 months
April 26, 2023
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Active Magnesium Containing Toothpaste (ROCS)
Active magnesium containing toothpaste can find to be effective in reducing plaque of Turesky-Modified Quinley-Hein-Plaque-Index (TMQHPI) score when compare to Fluoride toothpaste with single-use brushing in children
1 month
Study Arms (2)
Active Magnesium Containing Toothpaste-ROCS
EXPERIMENTALThe participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the test.In the first stage, the preliminary plaque in the children will record by the first researcher using plaque dye.After plaque disclosing the researcher brush children's teeth with ROCS active magnesium toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.
Fluoride Toothpaste-COLGATE
EXPERIMENTALAfter 2 weeks, the same participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the retest.Initial, the preliminary plaque in the children will record by the first researcher using plaque dye. After plaque disclosing the researcher brush children's teeth with Colgate fluoride toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.
Interventions
Using two different toothpastes for removal of the dental plaque in children.
Eligibility Criteria
You may qualify if:
- Patients aged 9-12 years
- The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
- Absence of orthodontic appliances/brackets
- No physical limitations
- No previous trauma history
- It was determined as the absence of soft-hard tissue pathology.
You may not qualify if:
- Patients not between 9-12 years
- The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
- Presence of orthodontic appliances/brackets
- Physical limitations
- Previous trauma history
- It was determined as the presence of soft-hard tissue pathology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 22, 2023
Study Start
May 26, 2023
Primary Completion
January 26, 2024
Study Completion
December 1, 2024
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share