GingivitisNCT05766995
Evaluation of 3 Oral Self-care Regimens on Clinical Signs of Inflammation and Plaque
A study testing Waterpik Water Flosser, Oral-B Water Flosser and Waxed Dental Floss in people with Gingivitis, run by Water Pik, Inc. at 1 site in Canada.
Trial summary
To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Waterpik Water Flosser, Oral-B Water Flosser and Waxed Dental Floss
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2021to 3 Sep 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have provided written informed consent prior to being entered into the study.
- Be between 18 and 75 years of age, male or female.
- Have at least twenty (20) natural teeth (5 evaluable in each quadrant) with scorable facial and lingual surfaces as determined by the clinical examiner.
- Nonsmoking (assessed as < 1 cigarette every day for at least a year).
- Have a mean baseline plaque index score of ≥0.60 as determined by the Rustogi Modification of the Navy Plaque Index (RMNPI).
- Have a mean baseline gingival index score of ≥1.75 as determined by the Modified Gingival Index (MGI).
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- Have a mean bleeding on probing score of 50%.
- Have probe readings ≤4 mm.
- Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study.
- Agree to abstain from the use of chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study.
- Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating, drinking or chewing gum for 4 hours prior to each evaluation visit.
- Agree to comply with the conditions and schedule of the study.
Who cannot join
- Physical limitations or restrictions that might preclude normal use of devices.
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Supra- or subgingival calculus that might interfere with evaluations as determined by the clinical examiner.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the clinical examiner.
- Conditions requiring antibiotic treatment prior to dental procedures.
- History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable disease, (e.g. COVID-19, AIDS).
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- Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial.
- Chronic treatment (2-weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, Coumadin, nonsteroidal anti-inflammatory drugs, and aspirin (325 mg)) within 1- month of the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
- Have moderate to severe periodontal disease or being actively treated for periodontal disease.
- Concomitant periodontal therapy other than prophylaxis in the last 6 months.
- Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
- Subjects who participate in a gingivitis study in the past month.
- History of significant adverse event following use of oral hygiene products such as toothpastes and mouth rinses.
- Subjects who are allergic to any ingredients in Crest® Cavity Protection or Colgate® Cavity Protection toothpaste.
- Self-reported pregnancy or lactating women since hormonal changes can exaggerate gingival response to dental plaque.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Three Oral Self-care Regimens on Clinical Parameters of Inflammation and Plaque: Part 1 - a Four Week Randomized Controlled Trial
To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores.
Read the detailed description
The goal of this clinical trial was to compare the effect of different battery powered water in and adult population with mild to moderate gingivitis. The main questions it aims to answer are:
- Is there a difference between the two water flosser devices on gum bleeding scores?
- Is there a difference between the two water flosser devices on plaque accumulation and removal?
- Is there a difference between the two water flosser devices on signs of gingivitis?
Researchers will compare the two groups using a water flosser (experimental) to see how it compares to traditional brushing and flossing (control).
- Conditions
- Gingivitis
- Being tested
- Waterpik Water Flosser, Oral-B Water Flosser, Waxed Dental Floss
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waterpik Water FlosserDevice
Also called dental water jet, oral irrigator
A pulsating water flosser and jet tip designed to clean between the teeth and below the gingival margin.
Oral-B Water FlosserDevice
Also called dental water jet, oral irrigator
A water flosser and specialized tip that delivers water with microbubbles of air
Waxed Dental FlossDevice
Nylon string used to clean between the teeth manually
| Study group | Role | What they receive |
|---|---|---|
| Manual toothbrush and water flosser with standard jet tip | Experimental | Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening Receives: Device: Waterpik Water Flosser |
| Manual toothbrush and water flosser with targeted jet tip | Experimental | Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening Receives: Device: Oral-B Water Flosser |
| Manual toothbrush and dental floss | Active comparator | Brush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening Receives: Device: Waxed Dental Floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding
Measured: 4 weeks
Secondary outcomes (2)
Modified gingival index
Visual assessment of the gingival tissue. 0 = absence of inflammation, 1 = mild inflammation (slight change in color, little change in texture of any porting of but not the entire marginal or papillary gingival area), 3 = moderate inflammation (glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival area), 4 = severe inflammation (marked redness, edema and/or hypertrophy of the marginal or papillary gingival area, spontaneous bleeding, congestion, or ulceration.
Measured: 4 weeks
Rustogi Modification of Navy Plaque Index
Plaque is assessed for each tooth area (divided into 9 sections labeled A through I) and scored using the following scale: 0 = absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are scored and a mean plaque index is calculated for each subject at each examination. Subjects' scores were calculated for whole mouth (A through I), along the gingival margin (A through C), and at the proximal (approximal) areas (D and F).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start3 Aug 2021
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
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.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water Pik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Mancinelli Lyle, Principal investigator, Water Pik, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766995
- Sponsor's protocol ID
- 2021-WP-1
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three Oral Self-care Regimens on Clinical Parameters of Inflammation and Plaque: Part 1 - a Four Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05766995
- Acronym / sponsor ID
- 2021-WP-1
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Water Pik, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 13 Mar 2023 (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.
To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores.
Detailed description
The goal of this clinical trial was to compare the effect of different battery powered water in and adult population with mild to moderate gingivitis. The main questions it aims to answer are:
- Is there a difference between the two water flosser devices on gum bleeding scores?
- Is there a difference between the two water flosser devices on plaque accumulation and removal?
- Is there a difference between the two water flosser devices on signs of gingivitis?
Researchers will compare the two groups using a water flosser (experimental) to see how it compares to traditional brushing and flossing (control).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual toothbrush and water flosser with standard jet tip | Experimental | Device: Waterpik Water FlosserBrush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening |
| Manual toothbrush and water flosser with targeted jet tip | Experimental | Device: Oral-B Water FlosserBrush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening |
| Manual toothbrush and dental floss | Active comparator | Device: Waxed Dental FlossBrush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have provided written informed consent prior to being entered into the study.
- Be between 18 and 75 years of age, male or female.
- Have at least twenty (20) natural teeth (5 evaluable in each quadrant) with scorable facial and lingual surfaces as determined by the clinical examiner.
- Nonsmoking (assessed as < 1 cigarette every day for at least a year).
- Have a mean baseline plaque index score of ≥0.60 as determined by the Rustogi Modification of the Navy Plaque Index (RMNPI).
Key exclusion criteria (16 listed)
- Physical limitations or restrictions that might preclude normal use of devices.
- Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
- Supra- or subgingival calculus that might interfere with evaluations as determined by the clinical examiner.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the clinical examiner.
- Conditions requiring antibiotic treatment prior to dental procedures.
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 |
|---|---|---|
| Waterpik Water FlosserAlso: dental water jet, oral irrigatorA pulsating water flosser and jet tip designed to clean between the teeth and below the gingival margin. | Device | Manual toothbrush and water flosser with standard jet tip |
| Oral-B Water FlosserAlso: dental water jet, oral irrigatorA water flosser and specialized tip that delivers water with microbubbles of air | Device | Manual toothbrush and water flosser with targeted jet tip |
| Waxed Dental FlossNylon string used to clean between the teeth manually | Device | Manual toothbrush and dental floss |
Primary outcome
Bleeding on probing
Time frame: 4 weeks
Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding
2 secondary outcomes
Modified gingival index
Time frame: 4 weeks
Rustogi Modification of Navy Plaque Index
Time frame: 4 weeks
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 17 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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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.
Deborah Mancinelli Lyle principal investigator
Water Pik, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waterpik Water Flosser, Oral-B Water Flosser and Waxed Dental Floss in people with Gingivitis, run by Water Pik, Inc. at 1 site in Canada.
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 12 inclusion and 16 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 17 Mar 2023. 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 Canada. 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?
Bleeding on probing (time frame: 4 weeks). 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 17 Mar 2023.