Oral Plaque BiofilmUNMNCT03876353
University of New Mexico Dental Hygiene
A study testing Floss in people with Oral Plaque Biofilm, run by University of New Mexico at 1 site in United States.
Trial summary
To evaluate the efficacy of flossing in the removal of oral plaque biofilm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Plaque Biofilm
- What is being tested?
- Floss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 11 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any persons 18 years of age and able to consent
Who cannot join
- A person being edentulous or who have teeth that do not contact Allergy to erythrosine dye (red #3)
Trial locations and contacts
1 site in 1 country.
United States1 site
Universsity of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Efficacy of Flossing in the Removal of Oral Plaque Biofilm
To evaluate the efficacy of flossing in the removal of oral plaque biofilm.
Read the detailed description
Flossing is universally recognized in the dental profession as a primary component of oral hygiene. Data supports the correlation between flossing and disease prevention by ways of reducing gingival bleeding, gingivitis, and dental caries.(1, 2) However, a recent AP publication (3) questioning the validity of flossing as an efficacious preventative method has warranted that oral healthcare professionals address certain underlying assumptions about the practice. Specifically, there is a clear gap in the number of clinical effectiveness trials that measure the ability of flossing for the sole purpose of oral plaque biofilm removal. Such studies are urgently needed. At this moment we can only assume flossing's correlation with disease prevention also links flossing with effectively removing oral plaque biofilm. Due to the current research gaps, additional studies must be performed to address the needs highlighted by the absence of substantive research in this field.
Our long term goal is to evaluate if flossing is an effective oral health aid in the removal of oral plaque biofilm. The overall objective of this application is to provide a consistent measurement to confirm whether flossing is an effective oral care technique in removing disease causing oral plaque biofilm . The rationale that underlies this proposal comes from the many professional associations, such as the American Dental Association, American Dental Hygienists' Association, and the U.S. Department of Health and Human Services, that endorse flossing as an effective home care routine in oral disease prevention. Many oral health professionals would argue that flossing is effective in plaque removal, as they have seen the results anecdotally year after year, yet it is clear that additional studies are needed to move what is known anecdotally to what is known scientifically.
- Conditions
- Oral Plaque Biofilm
- Being tested
- Floss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlossOther
All participants will have half of their mouth flossed. Each participant will act as their own control.
| Study group | Role | What they receive |
|---|---|---|
| Left Side | Other | Each participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque Receives: Other: Floss |
| Right Side | Other | Each participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque Receives: Other: Floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure removal of oral plaque biofilm
Evaluate the correlation between flossing and oral plaque biofilm formation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start7 Jan 2019
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Plaque BiofilmStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsey Lee, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876353
- Sponsor's protocol ID
- 17-419
- Acronym
- UNM
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flossing in the Removal of Oral Plaque Biofilm
- ClinicalTrials.gov ID
- NCT03876353
- Acronym / sponsor ID
- UNM / 17-419
- Conditions
- Oral Plaque Biofilm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 15 Mar 2019 (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 evaluate the efficacy of flossing in the removal of oral plaque biofilm.
Detailed description
Flossing is universally recognized in the dental profession as a primary component of oral hygiene. Data supports the correlation between flossing and disease prevention by ways of reducing gingival bleeding, gingivitis, and dental caries.(1, 2) However, a recent AP publication (3) questioning the validity of flossing as an efficacious preventative method has warranted that oral healthcare professionals address certain underlying assumptions about the practice. Specifically, there is a clear gap in the number of clinical effectiveness trials that measure the ability of flossing for the sole purpose of oral plaque biofilm removal. Such studies are urgently needed. At this moment we can only assume flossing's correlation with disease prevention also links flossing with effectively removing oral plaque biofilm. Due to the current research gaps, additional studies must be performed to address the needs highlighted by the absence of substantive research in this field.
Our long term goal is to evaluate if flossing is an effective oral health aid in the removal of oral plaque biofilm. The overall objective of this application is to provide a consistent measurement to confirm whether flossing is an effective oral care technique in removing disease causing oral plaque biofilm . The rationale that underlies this proposal comes from the many professional associations, such as the American Dental Association, American Dental Hygienists' Association, and the U.S. Department of Health and Human Services, that endorse flossing as an effective home care routine in oral disease prevention. Many oral health professionals would argue that flossing is effective in plaque removal, as they have seen the results anecdotally year after year, yet it is clear that additional studies are needed to move what is known anecdotally to what is known scientifically.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Side | Other | Other: FlossEach participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque |
| Right Side | Other | Other: FlossEach participant who participate will have half of their mouth flossed. Either the right or the left side. The investigator will not know which side has been flossed prior to documenting any tooth surfaces with residual plaque |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any persons 18 years of age and able to consent
Key exclusion criteria (1 listed)
- A person being edentulous or who have teeth that do not contact Allergy to erythrosine dye (red #3)
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 |
|---|---|---|
| FlossAll participants will have half of their mouth flossed. Each participant will act as their own control. | Other | Left Side, Right Side |
Primary outcome
measure removal of oral plaque biofilm
Time frame: 15 minutes
Evaluate the correlation between flossing and oral plaque biofilm formation
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 15 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floss in people with Oral Plaque Biofilm, run by University of New Mexico 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 1 inclusion and 1 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 15 Mar 2019. 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?
measure removal of oral plaque biofilm (time frame: 15 minutes). 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 15 Mar 2019.