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A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Primary Purpose

Dental Plaque, Dental Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
China Crest® Pro-health 7 Complete Toothpaste
China Crest® Cavity Protection Toothpaste
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • give written informed consent prior to their participation;
  • be 18 to 65 years of age at the time of enrollment;
  • agree not to participate in any other oral/dental product studies;
  • agree to delay any elective dentistry (including a dental prophylaxis);
  • agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
  • agree to return for the scheduled visits and follow study procedures;
  • be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
  • have more than 10 bleeding sites at visits 1-3
  • Consistency of bleeding site number at baseline may be considered;
  • have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
  • refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion Criteria:

  • teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
  • antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
  • medical conditions that the investigator considers significant and that may compromise the evaluation of study results
  • currently participating in any other clinical trial
  • participated in a clinical trial for plaque/gingivitis within the previous 30 days
  • pregnant or lactating
  • orthodontic appliances or removable partial dentures
  • soft or hard tissue tumor of the oral cavity
  • advanced periodontal disease
  • history of hepatitis, diabetes, or other communicable diseases
  • history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  • history of significant adverse effects following the use of oral hygiene products such as toothpaste
  • oral pathoses that could interfere with compliance and/or examinations or that need treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    Oral care regimen

    Toothbrush and toothpaste

    Outcomes

    Primary Outcome Measures

    Gingivitis
    Gingivitis was assessed according to the Gingival Bleeding Index
    Gingivitis
    Gingivitis was assessed according to the Gingival Bleeding Index
    Gingivitis
    Gingivitis was assessed according to the Gingival Bleeding Index
    Gingivitis
    Gingivitis was assessed according to the Gingival Bleeding Index

    Secondary Outcome Measures

    Plaque Examination
    The Modified Turesky Plaque Index was used to examine plaque.
    Plaque Examination
    The Modified Turesky Plaque Index was used to examine plaque.
    Plaque Examination
    The Modified Turesky Plaque Index was used to examine plaque.
    Plaque Examination
    The Modified Turesky Plaque Index was used to examine plaque.

    Full Information

    First Posted
    March 24, 2015
    Last Updated
    October 4, 2017
    Sponsor
    Procter and Gamble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02401360
    Brief Title
    A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
    Official Title
    A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Procter and Gamble

    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
    This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Oral care regimen
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Toothbrush and toothpaste
    Intervention Type
    Drug
    Intervention Name(s)
    China Crest® Pro-health 7 Complete Toothpaste
    Intervention Description
    Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
    Intervention Type
    Drug
    Intervention Name(s)
    China Crest® Cavity Protection Toothpaste
    Intervention Description
    Crest® meliliangje manual toothbrush
    Primary Outcome Measure Information:
    Title
    Gingivitis
    Description
    Gingivitis was assessed according to the Gingival Bleeding Index
    Time Frame
    Day 0
    Title
    Gingivitis
    Description
    Gingivitis was assessed according to the Gingival Bleeding Index
    Time Frame
    Day 3
    Title
    Gingivitis
    Description
    Gingivitis was assessed according to the Gingival Bleeding Index
    Time Frame
    Day 10
    Title
    Gingivitis
    Description
    Gingivitis was assessed according to the Gingival Bleeding Index
    Time Frame
    Day 24
    Secondary Outcome Measure Information:
    Title
    Plaque Examination
    Description
    The Modified Turesky Plaque Index was used to examine plaque.
    Time Frame
    Day 0
    Title
    Plaque Examination
    Description
    The Modified Turesky Plaque Index was used to examine plaque.
    Time Frame
    Day 3
    Title
    Plaque Examination
    Description
    The Modified Turesky Plaque Index was used to examine plaque.
    Time Frame
    Day 10
    Title
    Plaque Examination
    Description
    The Modified Turesky Plaque Index was used to examine plaque.
    Time Frame
    Day 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: give written informed consent prior to their participation; be 18 to 65 years of age at the time of enrollment; agree not to participate in any other oral/dental product studies; agree to delay any elective dentistry (including a dental prophylaxis); agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study; agree to return for the scheduled visits and follow study procedures; be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study; have more than 10 bleeding sites at visits 1-3 Consistency of bleeding site number at baseline may be considered; have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment. Exclusion Criteria: teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam medical conditions that the investigator considers significant and that may compromise the evaluation of study results currently participating in any other clinical trial participated in a clinical trial for plaque/gingivitis within the previous 30 days pregnant or lactating orthodontic appliances or removable partial dentures soft or hard tissue tumor of the oral cavity advanced periodontal disease history of hepatitis, diabetes, or other communicable diseases history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures history of significant adverse effects following the use of oral hygiene products such as toothpaste oral pathoses that could interfere with compliance and/or examinations or that need treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao He, DDS, PhD
    Organizational Affiliation
    Procter and Gamble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

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