InflammationNCT02187185
Salivary Inflammatory Biomarkers: Predictors & Comparative Effects of Sonicare/Elite-Flexcare in Stages of Perio Disease
A study testing Sonicare/Elite-Flexcare Toothbrush and Manual Toothbrush in people with Inflammation and Periodontitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This research study has 2 aims. One aim is to see if saliva testing can show if a person has healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Periodontitis
- What is being tested?
- Sonicare/Elite-Flexcare Toothbrush and Manual Toothbrush
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult males or females between the ages of 18 and 75 years (inclusive).
- able and willing to follow study procedures and instructions.
- read, understood and signed an informed consent form.
- present with at least 8 teeth in the functional dentition with a minimum of 3 adjacent teeth with interproximal papilla in each posterior sextant that will have the stent.
- be in good general health.
- present with one of the following five categories to be considered for enrollment
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- BGI health (all PD<3mm, BOP<10%)
- BGI-gingivitis (all PD≤3mm, BOP≥10%)
- BGI-P1 (1+ site with PD>3mm, BOP≤10%)
- BGI-P2 (1+ site with PD>3mm, BOP>10% but BOP≤50%)
- BGI-P3 (1+ site with PD>3mm, BOP>50%)
Who cannot join
- chronic disease with oral manifestations or active infectious diseases such as hepatitis, HIV or tuberculosis.
- gross oral pathology.
- treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
- chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants, non-steroidal anti-inflammatory drugs, high dose aspirin such as >100mg per day) within one month of the screening examination.
- ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
- clinically significant organ disease including impaired renal function, and/or any bleeding disorder.
Show all 10Show fewer
- severe unrestored caries, or any condition that is likely to require antibiotic treatment during the study, including the need for prophylactic antibiotic.
- use any tobacco products or who have used tobacco products within the previous six months of the screening examination.
- pregnant, or expect to become pregnant within the next three months and individuals nursing.
- dental appliances that will interfere with stent construction.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: Studies of Salivary Inflammatory Biomarkers During Biofilm Overgrowth: Confirmation of Predictors and Comparative Effects of Sonicare/Elite-Flexcare in Various Stages of Periodontal Disease
This research study has 2 aims. One aim is to see if saliva testing can show if a person has healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on periodontitis.
Read the detailed description
Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare Flexcare tooth brushing following experimental induction of biofilm overgrowth in various periodontal conditions.
This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the utility of candidate inflammatory biomarkers within saliva to discriminate between health, gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus inactive states of periodontal disease to see if these basal levels can predict the clinical response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and P3].
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
- Inflammation, Periodontitis
- Being tested
- Sonicare/Elite-Flexcare Toothbrush, Manual Toothbrush
- Keywords
- Inflammatory biomarkers, Periodontitis
- Medical subject headings
- Inflammation, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonicare/Elite-Flexcare ToothbrushOther
Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles
Manual ToothbrushOther
traditional (non-mechanical) toothbrush with nylon bristles and plastic handle
| Study group | Role | What they receive |
|---|---|---|
| Sonicare Elite-Flexcare | Active comparator | Arm 1 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the Sonicare/Elite/Flexcare toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. Receives: Other: Sonicare/Elite-Flexcare Toothbrush |
| Manual Toothbrush | Active comparator | Arm 2 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the manual toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. Receives: Other: Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.
Measured: Four weeks
Secondary outcomes (1)
Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).
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 posted10 Jul 2014 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 175 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, The University of North Carolina at Chapel Hill School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187185
- Sponsor's protocol ID
- 09-0627
- Status last verified
- Jan 2017
- First submitted
- 8 Jul 2014
- 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
- Studies of Salivary Inflammatory Biomarkers During Biofilm Overgrowth: Confirmation of Predictors and Comparative Effects of Sonicare/Elite-Flexcare in Various Stages of Periodontal Disease
- ClinicalTrials.gov ID
- NCT02187185
- Acronym / sponsor ID
- 09-0627
- Conditions
- Inflammation, Periodontitis
- Keywords
- Inflammatory biomarkers, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Philips Oral Healthcare
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Jul 2014 (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.
This research study has 2 aims. One aim is to see if saliva testing can show if a person has healthy gum tissue, gingivitis, or one of three degrees of periodontitis - mild, moderate, or severe. The second aim is to examine the effect of the Sonicare Elite/Flexcare toothbrush on periodontitis.
Detailed description
Randomized controlled trial to determine clinical and inflammatory benefits of Sonicare Flexcare tooth brushing following experimental induction of biofilm overgrowth in various periodontal conditions.
This research study has both a Diagnostic Aim and a Treatment Aim. Aim #1 is to examine the utility of candidate inflammatory biomarkers within saliva to discriminate between health, gingivitis, mild, moderate and severe periodontis; and to discriminate between active versus inactive states of periodontal disease to see if these basal levels can predict the clinical response to biofilm overgrowth among various periodontal conditions; Aim #2 is to extend the claim of the anti-inflammatory and anti-infective efficacy of the Sonicare/Elite-Flexcare as compared to manual brushing to include 4 levels of periodontal disease [BGI-G, P1, P2 and P3].
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonicare Elite-Flexcare | Active comparator | Other: Sonicare/Elite-Flexcare ToothbrushArm 1 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the Sonicare/Elite/Flexcare toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. |
| Manual Toothbrush | Active comparator | Other: Manual ToothbrushArm 2 participants will abstain from brushing and flossing teeth in selected sites which will typically be one maxillary and mandibular posterior sextant during a three week, no-hygiene phase via placement of acrylic stents. After the stent-induced biofilm overgrowth (SIBO) induction, the resolution phase of the study will involve a randomization that places half of the subjects on the manual toothbrush. Thus, the resolution phase is a RCT designed to treat SIBO in subjects with varying levels of disease. Participants will reinstate normal full mouth oral hygiene and daily plaque control, exclusive of flossing, with dispensed dentifrice and toothbrush. Participants will be followed for four weeks during SIBO resolution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- adult males or females between the ages of 18 and 75 years (inclusive).
- able and willing to follow study procedures and instructions.
- read, understood and signed an informed consent form.
- present with at least 8 teeth in the functional dentition with a minimum of 3 adjacent teeth with interproximal papilla in each posterior sextant that will have the stent.
- be in good general health.
Key exclusion criteria (10 listed)
- chronic disease with oral manifestations or active infectious diseases such as hepatitis, HIV or tuberculosis.
- gross oral pathology.
- treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
- chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, anticoagulants, non-steroidal anti-inflammatory drugs, high dose aspirin such as >100mg per day) within one month of the screening examination.
- ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
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 |
|---|---|---|
| Sonicare/Elite-Flexcare ToothbrushPhilips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles | Other | Sonicare Elite-Flexcare |
| Manual Toothbrushtraditional (non-mechanical) toothbrush with nylon bristles and plastic handle | Other | Manual Toothbrush |
Primary outcome
Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks.
Time frame: Four weeks
1 secondary outcome
Identification of salivary biomarkers that can distinguish between and among the 5 disease categories (health, gingivitis, and 3 levels of periodontal disease).
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 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
The University of North Carolina at Chapel Hill 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 Sonicare/Elite-Flexcare Toothbrush and Manual Toothbrush in people with Inflammation and Periodontitis, 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 11 inclusion and 10 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?
Change from baseline in (inflammatory biomarkers?) among a range of periodontal disease groups after using Sonicare Elite/Flexcare versus manual toothbrush for four weeks. (time frame: Four 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 31 Aug 2018.