GingivitisConnectedNCT04221334
Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush
A study testing Electric Toothbrush and oral health care application in people with Gingivitis and Plaque, Dental, run by Colgate Palmolive at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque, Dental
- What is being tested?
- Electric Toothbrush and oral health care application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 27 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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),
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- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
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.
Read the 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.
- Conditions
- Gingivitis, Plaque, Dental
- Being tested
- Electric Toothbrush, oral health care application
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric ToothbrushDevice
Electric Toothbrush used to remove dental plaque and resolve gingivitis
oral health care applicationOther
phone application that shows the user brushing efficiency real time
| Study group | Role | What they receive |
|---|---|---|
| Experimental Toothbrush 1 | Active comparator | 1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. Receives: Device: Electric Toothbrush; Other: oral health care application |
| Experimental Toothbrush 2 | Active comparator | 2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. Receives: Device: Electric Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean dental plaque
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
Measured: 3 and 6 weeks of product use
change in mean gingivitis
gingivitis measurement is served as secondary efficacy variable
Measured: 3 and 6 weeks of product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start30 Apr 2019
- Primary completion3 Jul 2019
- Study completion27 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loma Linda University
- Responsible party
- Sponsor
- Investigators
- Yiming Yi, DDS/PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221334
- Sponsor's protocol ID
- CRO-2018-12-CTB-PLA-LLU-YPZ
- Acronym
- Connected
- Status last verified
- Jan 2020
- First submitted
- 30 Sep 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
- ClinicalTrials.gov ID
- NCT04221334
- Acronym / sponsor ID
- Connected / CRO-2018-12-CTB-PLA-LLU-YPZ
- Conditions
- Gingivitis, Plaque, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Loma Linda University
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 27 Jul 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Toothbrush 1 | Active comparator | Device: Electric Toothbrush, Other: oral health care application1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. |
| Experimental Toothbrush 2 | Active comparator | Device: Electric Toothbrush2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • 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,
Key exclusion criteria (18 listed)
- • 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric ToothbrushElectric Toothbrush used to remove dental plaque and resolve gingivitis | Device | Experimental Toothbrush 1, Experimental Toothbrush 2 |
| oral health care applicationphone application that shows the user brushing efficiency real time | Other | Experimental Toothbrush 1 |
Primary outcome
change in mean dental plaque
Time frame: 3 and 6 weeks of product use
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
change in mean gingivitis
Time frame: 3 and 6 weeks of product use
gingivitis measurement is served as secondary efficacy variable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiming Yi, DDS/PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Toothbrush and oral health care application in people with Gingivitis and Plaque, Dental, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mean dental plaque (time frame: 3 and 6 weeks of product use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.