GingivitisPAU2NCT01559987
Dental Plaque Removal Study
A study testing Manual Toothbrush only, MTB + Waterpik Ultra Water Flosser 'High' and MTB + Floss (MTB+Floss) in people with Gingivitis and Gum Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to investigate water flow in dental devices and to understand the function of water flow behind oral hygiene improvements. Understanding this mechanism may help with the design of future products. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingivitis, Gum Disease
- What is being tested?
- Manual Toothbrush only, MTB + Waterpik Ultra Water Flosser 'High' and MTB + Floss (MTB+Floss)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are in good general health
- are 18 - 75 years old;
- have and will abstain from all oral care in the 12 hours prior to each scheduled appointment, but no more than 18 hours prior.
- have and will abstain from consumption of apples and other sticky fruits in the 12 hours prior to each appointment.
- agree to abstain from eating, drinking, chewing gum, and the use of breath mints, etc in the one hour preceding saliva collection at Visits 2 and 3
- have a minimum of 20 natural teeth (excluding 3rd molars);
Show all 14Show fewer
- have 2 qualifying Interproximal Unit test sites in each posterior quadrant from 3 approximating teeth (see Section 5.1.1, Interproximal Unit (IU)Test Site Selection, for definition);
- present with one of the following three categories:
- BGI-gingivitis: all PD<3mm, BOP>10%;
- BGI-periodontitis (P2): 1+ site with PD>3mm, BOP>10% but <50%
- BGI-periodontitis (P3): 1+ site with PD>3mm, BOP>50%
- have provided written informed consent and are willing to participate and be available at all times required for participation
- are willing and able to fully understand and comply with the written and verbal study instructions provided in English
- agree to return all study materials at the final visit
Who cannot join
- have systemic diseases, Down's syndrome, or known AIDS/HIV;
- have Diabetes
- are a smoker
- are pregnant or nursing by participant report;
- have a cardiac pacemaker or AICD
- are undergoing or require extensive dental or orthodontic treatment;
Show all 19Show fewer
- have had oral or gum surgery in the previous 2 months;
- require antibiotic treatment for dental appointments;
- have used antibiotics within 4 weeks of enrollment
- are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin)
- have heavy deposits of calculus, either supragingival and/or subgingival;
- have extensive crown or bridge work and/or rampant decay;
- currently use bleaching trays;
- have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
- have a professional prophylaxis within 4 weeks of study;
- have participated in a prior study ≤ 20 days;
- participated in Philips study DRC-0742;
- are employed by an oral healthcare products company or dental research institution (i.e., dental school: administrative staff, assistants, hygienists, and research students).
- are a dentist, dental student or dental professional
Trial locations and contacts
1 site in 1 country.
United States1 site
General and Oral Health Center
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects From Oral Cleaning Modalities
The purpose of this research study is to investigate water flow in dental devices and to understand the function of water flow behind oral hygiene improvements. Understanding this mechanism may help with the design of future products.
Read the detailed description
The overall clinical response (plaque, gingivitis, bleeding) in participants with varying stages of gingival health as well as the causative or indicative hallmarks of selected biological responses underpinning the overt clinical manifestations described above will be evaluated. The chief biological response that will be investigated is how a reduction in the concentration of bacterial lipopolysaccharide endotoxins (LPS) in interproximal plaque may influence improvements in the clinical response (e.g., through mitigation of bleeding) when compared to a change in the plaque biomass within which a large component of the endotoxins reside. The hypothesis is that improvements in clinical bleeding may result more from the removal or reduction of toxic bacterial products that serve as the direct impetus of the inflammatory response rather than from sheer bulk removal of interproximal plaque. From a methods development perspective, this study will also assess the feasibility of measuring endotoxin load from clinical samples. Ultimately it is anticipated that a comprehensive evaluation of clinical benefits conferred by continuous fluid streaming will emerge upon analysis of the relationships between clinical and biological data sets, particularly where causal relationships may exist between both parameters.
The devices used in this study are subject only to Class I (general controls) and considered exempt from the premarket notification procedures and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.
- Conditions
- Gingivitis, Gum Disease
- Being tested
- Manual Toothbrush only, MTB + Waterpik Ultra Water Flosser 'High', MTB + Floss (MTB+Floss)
- Keywords
- plaque removal methods, oral hygiene devices
- Medical subject headings
- Gingivitis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Toothbrush onlyOther
ADA (American Dental Association) Reference Manual Toothbrush (MTB)
MTB + Waterpik Ultra Water Flosser 'High'Other
MTB + Waterpik Ultra Water Flosser 'High'
MTB + Floss (MTB+Floss)Other
MTB + Floss (MTB+Floss)
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | ADA (American Dental Association) Reference Manual Toothbrush (MTB) Receives: Other: Manual Toothbrush only |
| Test | Other | MTB + Floss Receives: Other: MTB + Floss (MTB+Floss) |
| MTB + Waterpik Ultra Water Flosser High | Experimental | MTB + Waterpik Ultra Water Flosser High Receives: Other: MTB + Waterpik Ultra Water Flosser 'High' |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone
The primary endpoint of this study is the residual protein concentration in posterior sites following in-clinic use of MTB+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone.
Measured: Baseline and Week 2
Secondary outcomes (2)
Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level).
To evaluate the impact of a fluid cleaning principle (MTB+Waterpik Waterflosser) relative to MTB+Floss and MTB alone on clinical outcomes: Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level.
Measured: Baseline and Week 2
Number of Adverse Events and Intraoral Exams
Safety endpoints based on adverse event reports and intraoral exam (soft tissue evaluation)findings.
Measured: Baseline and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Oral Healthcare
- Responsible party
- Sponsor
- Investigators
- Steven Offenbacher, DDS, PhD, MMSc, Principal investigator, UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559987
- Sponsor's protocol ID
- MAH-11-0059
- Acronym
- PAU2
- Status last verified
- Jan 2017
- First submitted
- 6 Mar 2012
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects From Oral Cleaning Modalities
- ClinicalTrials.gov ID
- NCT01559987
- Acronym / sponsor ID
- PAU2 / MAH-11-0059
- Conditions
- Gingivitis, Gum Disease
- Keywords
- plaque removal methods, oral hygiene devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Philips Oral Healthcare
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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 purpose of this research study is to investigate water flow in dental devices and to understand the function of water flow behind oral hygiene improvements. Understanding this mechanism may help with the design of future products.
Detailed description
The overall clinical response (plaque, gingivitis, bleeding) in participants with varying stages of gingival health as well as the causative or indicative hallmarks of selected biological responses underpinning the overt clinical manifestations described above will be evaluated. The chief biological response that will be investigated is how a reduction in the concentration of bacterial lipopolysaccharide endotoxins (LPS) in interproximal plaque may influence improvements in the clinical response (e.g., through mitigation of bleeding) when compared to a change in the plaque biomass within which a large component of the endotoxins reside. The hypothesis is that improvements in clinical bleeding may result more from the removal or reduction of toxic bacterial products that serve as the direct impetus of the inflammatory response rather than from sheer bulk removal of interproximal plaque. From a methods development perspective, this study will also assess the feasibility of measuring endotoxin load from clinical samples. Ultimately it is anticipated that a comprehensive evaluation of clinical benefits conferred by continuous fluid streaming will emerge upon analysis of the relationships between clinical and biological data sets, particularly where causal relationships may exist between both parameters.
The devices used in this study are subject only to Class I (general controls) and considered exempt from the premarket notification procedures and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Manual Toothbrush onlyADA (American Dental Association) Reference Manual Toothbrush (MTB) |
| Test | Other | Other: MTB + Floss (MTB+Floss)MTB + Floss |
| MTB + Waterpik Ultra Water Flosser High | Experimental | Other: MTB + Waterpik Ultra Water Flosser 'High'MTB + Waterpik Ultra Water Flosser High |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- are in good general health
- are 18 - 75 years old;
- have and will abstain from all oral care in the 12 hours prior to each scheduled appointment, but no more than 18 hours prior.
- have and will abstain from consumption of apples and other sticky fruits in the 12 hours prior to each appointment.
- agree to abstain from eating, drinking, chewing gum, and the use of breath mints, etc in the one hour preceding saliva collection at Visits 2 and 3
Key exclusion criteria (19 listed)
- have systemic diseases, Down's syndrome, or known AIDS/HIV;
- have Diabetes
- are a smoker
- are pregnant or nursing by participant report;
- have a cardiac pacemaker or AICD
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 |
|---|---|---|
| Manual Toothbrush onlyADA (American Dental Association) Reference Manual Toothbrush (MTB) | Other | Control |
| MTB + Waterpik Ultra Water Flosser 'High'MTB + Waterpik Ultra Water Flosser 'High' | Other | MTB + Waterpik Ultra Water Flosser High |
| MTB + Floss (MTB+Floss)MTB + Floss (MTB+Floss) | Other | Test |
Primary outcome
residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone
Time frame: Baseline and Week 2
The primary endpoint of this study is the residual protein concentration in posterior sites following in-clinic use of MTB+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone.
2 secondary outcomes
Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level).
Time frame: Baseline and Week 2
Number of Adverse Events and Intraoral Exams
Time frame: Baseline and week 2
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 31 Aug 2018.
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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.
Steven Offenbacher, DDS, PhD, MMSc principal investigator
UNC School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Toothbrush only, MTB + Waterpik Ultra Water Flosser 'High' and MTB + Floss (MTB+Floss) in people with Gingivitis and Gum Disease, run by University of North Carolina, Chapel Hill 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 14 inclusion and 19 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 31 Aug 2018. 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?
residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone (time frame: Baseline and Week 2). 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 31 Aug 2018.