Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush (Connected)
Primary Purpose
Gingivitis, Plaque, Dental
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electric Toothbrush
oral health care application
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
- • Male and female subjects had to be between the ages of 18 and 70 (inclusive),
- • Subjects needed to be available for the duration (6 weeks) of the study,
- • Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
- • Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
- • Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
- • Subjects had to sign an Informed Consent form,
- • Subjects had to be in general good health and
- • Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.
Exclusion:
- • Medical condition which require pre-medication prior to dental visits/procedures,
- • The presence of partial removable dentures,
- • Subjects who had advanced periodontal disease (gum disease),
- • Five (5) or more decayed or untreated dental sites at screening (cavities),
- • Subjects with diseases of the soft or hard oral tissues,
- • Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
- • Dry mouth as a result of a medication or medical condition,
- • Use of drugs that can currently affect salivary flow,
- • Use of antibiotics one (1) month prior to or during this study,
- • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
- • Chronic (>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),
- • Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,
- • Pregnant or breast-feeding women were excluded from the study,
- • Subjects who participated in any other clinical study in the month preceding this study,
- • Allergic to common dentifrice ingredients,
- • Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,
- • Immune compromised individuals (AIDS, immune suppressive drug therapy) and
- • History of infectious disease or other blood borne diseases (Hepatitis series, HIV).
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Experimental Toothbrush 1
Experimental Toothbrush 2
Arm Description
1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
Outcomes
Primary Outcome Measures
change in mean dental plaque
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
change in mean gingivitis
gingivitis measurement is served as secondary efficacy variable
Secondary Outcome Measures
Full Information
NCT ID
NCT04221334
First Posted
September 30, 2019
Last Updated
January 7, 2020
Sponsor
Colgate Palmolive
Collaborators
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT04221334
Brief Title
Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
Acronym
Connected
Official Title
Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
Collaborators
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.
Detailed Description
A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque, Dental
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Product Code: XX Brush twice daily (morning and evening) for at least 2 minutes each time Cover the entire length of bristles with toothpaste
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Toothbrush 1
Arm Type
Active Comparator
Arm Description
1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
Arm Title
Experimental Toothbrush 2
Arm Type
Active Comparator
Arm Description
2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral.
Intervention Type
Device
Intervention Name(s)
Electric Toothbrush
Intervention Description
Electric Toothbrush used to remove dental plaque and resolve gingivitis
Intervention Type
Other
Intervention Name(s)
oral health care application
Intervention Description
phone application that shows the user brushing efficiency real time
Primary Outcome Measure Information:
Title
change in mean dental plaque
Description
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
Time Frame
3 and 6 weeks of product use
Title
change in mean gingivitis
Description
gingivitis measurement is served as secondary efficacy variable
Time Frame
3 and 6 weeks of product use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Male and female subjects had to be between the ages of 18 and 70 (inclusive),
• Subjects needed to be available for the duration (6 weeks) of the study,
• Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
• Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
• Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
• Subjects had to sign an Informed Consent form,
• Subjects had to be in general good health and
• Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.
Exclusion:
• Medical condition which require pre-medication prior to dental visits/procedures,
• The presence of partial removable dentures,
• Subjects who had advanced periodontal disease (gum disease),
• Five (5) or more decayed or untreated dental sites at screening (cavities),
• Subjects with diseases of the soft or hard oral tissues,
• Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
• Dry mouth as a result of a medication or medical condition,
• Use of drugs that can currently affect salivary flow,
• Use of antibiotics one (1) month prior to or during this study,
• Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
• Chronic (>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),
• Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,
• Pregnant or breast-feeding women were excluded from the study,
• Subjects who participated in any other clinical study in the month preceding this study,
• Allergic to common dentifrice ingredients,
• Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,
• Immune compromised individuals (AIDS, immune suppressive drug therapy) and
• History of infectious disease or other blood borne diseases (Hepatitis series, HIV).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiming Yi, DDS/PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
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