GingivitisNCT04804670
To Compare the Effectiveness of Three Self-care Oral Hygiene Regimens
A study testing Power device A, Power device B and Routine Oral Hygiene in people with Gingivitis, run by Water Pik, Inc. at 1 site in Canada.
Trial summary
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Power device A, Power device B and Routine Oral Hygiene
- 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
- 19 Oct 2020to 8 Jan 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided written informed consent prior to being entered into the study
- Have at least twenty (20) natural teeth (5 evaluable teeth in each quadrant) with scorable facial and lingual surfaces as determined by examiner
- No tobacco use or other substance via the mouth including but not limited to cigarettes, cigars, smokeless tobacco hookah, cannabis, snuff, chew, or vaping electronic cigarettes
- Have a minimum of 50% bleeding on probing sites (6 sites per tooth, total of 120 - 168 total sites)
- Have probing depths </= 4 mm
- Have a mean baseline gingival index score of >/= to 1.75 as determined by the Modified Gingival Index.
Show all 10Show fewer
- 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 aids other than the study procedures for the duration of the study
- Agree to refrain from all oral hygiene on morning of each evaluation visit
- Agree to comply with the conditions ad schedule of the study
Who cannot join
- Physical limitations or restrictions that might preclude normal tooth brushing.
- 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.
- Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the examiner.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the 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. cardiomyopathy, immunocompromised).
Show all 16Show fewer
- Subjects with several fully crowned or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Treatment with antibiotics within 6 months 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 the month before the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment.
- Have severe periodontal disease or being actively treated for periodontal disease.
- Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis.
- Concomitant periodontal therapy other than prophylaxis in the last 3 months.
- Professional prophylaxis within 1 month prior to the baseline clinical evaluation.
- Subjects who participated 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.
- Self-reported pregnancy or lactating women or planning to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Determine the Effectiveness of a Sonic Toothbrush and Interdental Device With Different Toothbrush Designs to Brushing and Flossing on Plaque, Gingival Bleeding and Inflammation: a 4-week Randomized Controlled Trial
The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2).
Read the detailed description
Data will be analyzed and reported as mean. The target population is approximately 105 healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, subjects will be randomly assigned in a 1:1:1 ratio.
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi Modification of Navy Plaque Index pre \& Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days).
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed-up.
Subjects will complete a questionnaure at the completion of the study.
- Conditions
- Gingivitis
- Being tested
- Power device A, Power device B, Routine Oral Hygiene
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power device ADevice
Oral hygiene regimen completed daily
Power device BDevice
Oral hygiene regimen completed daily
Routine Oral HygieneDevice
Oral hygiene regimen completed daily
| Study group | Role | What they receive |
|---|---|---|
| Sonic-Floss toothbrush and small brush head | Experimental | sonic toothbrush used for 2 minutes and water flosser used for 1 minute Receives: Device: Power device A |
| Sonic-Floss toothbrush and full size brush head | Experimental | sonic toothbrush used for 2 minutes and water flosser used for 1 minute Receives: Device: Power device B |
| Manual brushing and flossing | Active comparator | American Dental Association standard manual toothbrush used for 2 minutes and dental floss all teeth Receives: Device: Routine Oral Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing
Binary measure of present = 1 or absent =0. Mean score is determined by adding the total number of sites with bleeding (six per tooth) and dividing by the total evaluable sites.
Measured: 4 weeks
Modified Gingival Index
Index uses a 0 - 4 point scale
Measured: 4 weeks
Secondary outcomes (1)
Rustogi Modification of the Navy Plaque Index
Each tooth is scored using 9 sections for the facial and lingual surfaces.
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 posted18 Mar 2021
- Study start19 Oct 2020
- Primary completion20 Nov 2020
- Study completion8 Jan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water Pik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jimmy G Qaqish, BSc, Study director, All Sum Research Center Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804670
- Sponsor's protocol ID
- 28SFTBF2020
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Effectiveness of a Sonic Toothbrush and Interdental Device With Different Toothbrush Designs to Brushing and Flossing on Plaque, Gingival Bleeding and Inflammation: a 4-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04804670
- Acronym / sponsor ID
- 28SFTBF2020
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Water Pik, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 18 Mar 2021 (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 study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2).
Detailed description
Data will be analyzed and reported as mean. The target population is approximately 105 healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, subjects will be randomly assigned in a 1:1:1 ratio.
With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%.
The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks.
Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi Modification of Navy Plaque Index pre \& Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days).
Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed-up.
Subjects will complete a questionnaure at the completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sonic-Floss toothbrush and small brush head | Experimental | Device: Power device Asonic toothbrush used for 2 minutes and water flosser used for 1 minute |
| Sonic-Floss toothbrush and full size brush head | Experimental | Device: Power device Bsonic toothbrush used for 2 minutes and water flosser used for 1 minute |
| Manual brushing and flossing | Active comparator | Device: Routine Oral HygieneAmerican Dental Association standard manual toothbrush used for 2 minutes and dental floss all teeth |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provided written informed consent prior to being entered into the study
- Have at least twenty (20) natural teeth (5 evaluable teeth in each quadrant) with scorable facial and lingual surfaces as determined by examiner
- No tobacco use or other substance via the mouth including but not limited to cigarettes, cigars, smokeless tobacco hookah, cannabis, snuff, chew, or vaping electronic cigarettes
- Have a minimum of 50% bleeding on probing sites (6 sites per tooth, total of 120 - 168 total sites)
- Have probing depths </= 4 mm
Key exclusion criteria (16 listed)
- Physical limitations or restrictions that might preclude normal tooth brushing.
- 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.
- Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the examiner.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the 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 |
|---|---|---|
| Power device AOral hygiene regimen completed daily | Device | Sonic-Floss toothbrush and small brush head |
| Power device BOral hygiene regimen completed daily | Device | Sonic-Floss toothbrush and full size brush head |
| Routine Oral HygieneOral hygiene regimen completed daily | Device | Manual brushing and flossing |
Primary outcome
Bleeding on Probing
Time frame: 4 weeks
Binary measure of present = 1 or absent =0. Mean score is determined by adding the total number of sites with bleeding (six per tooth) and dividing by the total evaluable sites.
Modified Gingival Index
Time frame: 4 weeks
Index uses a 0 - 4 point scale
1 secondary outcome
Rustogi Modification of the 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 11 Oct 2021.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Jimmy G Qaqish, BSc study director
All Sum Research Center Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power device A, Power device B and Routine Oral Hygiene 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 10 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 11 Oct 2021. 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). 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 11 Oct 2021.