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Evaluation of Toothpaste on Dental Plaque

Primary Purpose

Dental Plaque

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toothpaste
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Active Magnesium Containing Toothpaste-ROCS

    Fluoride Toothpaste-COLGATE

    Arm Description

    The 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.

    After 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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    May 11, 2023
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05868590
    Brief Title
    Evaluation of Toothpaste on Dental Plaque
    Official Title
    Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 26, 2023 (Anticipated)
    Primary Completion Date
    January 26, 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Plaque

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Magnesium Containing Toothpaste-ROCS
    Arm Type
    Experimental
    Arm Description
    The 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.
    Arm Title
    Fluoride Toothpaste-COLGATE
    Arm Type
    Experimental
    Arm Description
    After 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.
    Intervention Type
    Other
    Intervention Name(s)
    Toothpaste
    Intervention Description
    Using two different toothpastes for removal of the dental plaque in children.
    Primary Outcome Measure Information:
    Title
    Active Magnesium Containing Toothpaste (ROCS)
    Description
    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
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Betul Kargul, Prof.Dr.
    Phone
    +905323267207
    Email
    bkargul@marmara.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nur Kodaman Dokumacigil, DDS
    Phone
    +905418091710
    Email
    nurkodaman92@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of Toothpaste on Dental Plaque

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