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
About this trial
This is an interventional treatment trial for Dental Plaque
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.
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
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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