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The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial

Primary Purpose

Plaque, Dental

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
brushing
Sponsored by
Heba sabbagh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plaque, Dental

Eligibility Criteria

8 Years - 9 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy children
  • age from 8 to 9
  • parents signed the consent form they attended morning session for brushing

Exclusion Criteria:

  • medical compromised children
  • parents did not sign the consent form Did not attend morning session

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Salvadora persica

    tooth brush

    Arm Description

    brush teeth with Salvadora persica "Miswak"

    brush with fluoridated tooth paste

    Outcomes

    Primary Outcome Measures

    green and vermillion
    plaque level

    Secondary Outcome Measures

    Full Information

    First Posted
    October 22, 2019
    Last Updated
    October 22, 2019
    Sponsor
    Heba sabbagh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04137393
    Brief Title
    The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
    Official Title
    The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    October 2017 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Heba sabbagh

    4. Oversight

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

    5. Study Description

    Brief Summary
    Objectives: to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children. Methods: A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Salvadora persica
    Arm Type
    Experimental
    Arm Description
    brush teeth with Salvadora persica "Miswak"
    Arm Title
    tooth brush
    Arm Type
    Active Comparator
    Arm Description
    brush with fluoridated tooth paste
    Intervention Type
    Combination Product
    Intervention Name(s)
    brushing
    Intervention Description
    mechanical and chemical plaque removal
    Primary Outcome Measure Information:
    Title
    green and vermillion
    Description
    plaque level
    Time Frame
    4 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy children age from 8 to 9 parents signed the consent form they attended morning session for brushing Exclusion Criteria: medical compromised children parents did not sign the consent form Did not attend morning session

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32054468
    Citation
    Sabbagh HJ, AlGhamdi KS, Mujalled HT, Bagher SM. The effect of brushing with Salvadora persica (miswak) sticks on salivary Streptococcus mutans and plaque levels in children: a clinical trial. BMC Complement Med Ther. 2020 Feb 13;20(1):53. doi: 10.1186/s12906-020-2847-3.
    Results Reference
    derived

    Learn more about this trial

    The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial

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