Gingival InflammationNCT04218994
The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
A study testing Flossing technique in people with Gingival Inflammation, run by Tufts University at 1 site in United States.
Trial summary
In this study, half of the participants will be asked to floss as normal, while the other half will receive professional instructions on flossing from a dentist. The investigators want to see if the participants who have professional flossing instructions are able to remove plaque in between the teeth more… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- Flossing technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 2 Dec 2018
- 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
- At least 18 years of age
- Subjects must show > 20% interproximal sites (mesial facial and mesial lingual and distal facial and distal lingual) with BoP. This includes mesial and distal sites next to edentulous areas.
- Subjects must have > 24 natural teeth including teeth with crowns with margins confluent with the natural tooth as long as they do not violate the biologic width.
- Third molars will be excluded from study; unless the third molars are in the anatomical position of second molars. However, subjects with third molars present will be accepted into the study unless there are other factors that exclude them.
- Subjects must report having had a professional dental prophylaxis within four months of beginning the study.
- Subjects must be willing to floss daily and to be taught and use a specific technique of flossing.
Who cannot join
- Subjects who use tobacco products.
- Subjects with fixed or removable orthodontic appliances
- Subjects with splinted fixed prostheses.
- Subjects who are incapable of flossing their teeth
- Subjects with defective interproximal restorations or interproximal caries that are clinically evident and impacting gingival health.
- Subjects where malposed teeth preclude the use of floss
Show all 10Show fewer
- Subjects with probing depth greater than or equal to 5mm.
- Subjects who are pregnant (self-reported) due to the greater bleeding tendency due to the hormonal changes.
- Subjects with a systemic disease that affects the gingiva or are taking medications of which affect the gingiva.
- Non-English speaking subjects, as study assessments and instructions will be in English only. There is no direct benefit to subjects for taking part in this study, therefore the exclusion of non-English speaking subjects is not an ethical concern.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
In this study, half of the participants will be asked to floss as normal, while the other half will receive professional instructions on flossing from a dentist. The investigators want to see if the participants who have professional flossing instructions are able to remove plaque in between the teeth more effectively, and have less gum bleeding over time. The investigators also want to see if participants who receive professional flossing instructions get better at the technique over time, and if they can match the dentist's skill by the end of the study.
Read the detailed description
Primary Aim: To determine whether subjects instructed with a specific flossing technique have less gingival inflammation as evidenced by bleeding on probing (BoP) than subjects without flossing instructions.
Secondary Aim: To compare the effect of flossing by a dental professional with a patient's self-flossing following instruction in removing interdental plaque.
Secondary Aim: To compare the completeness of plaque removal by the subjects instructed during the initial visit (Group A [test]) with their completeness at the final (fourth) visit.
Secondary Aim: To compare the clinician's completeness of plaque removal at the fourth visit with the completeness of plaque removal by the subjects in both groups (Groups A [test] and B [control]). Each group will be analyzed separately. In Group A, a comparison of the plaque removal by the subjects and by the clinician will made with respect to the completeness at the first visit versus the final visit.
- Conditions
- Gingival Inflammation
- Being tested
- Flossing technique
- Keywords
- flossing
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flossing techniqueOther
Subjects instructed on flossing technique
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects instructed on flossing technique. Receives: Other: Flossing technique |
| Group B | No intervention | No instructions for flossing provided. Subjects asked to continue their normal oral hygiene care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Bleeding Index
The examiner gently swiped the probe at the most apical portion of the gingival crevice from line angle to line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial (facial and lingual) and the distal (facial and lingual).
Measured: Change from Baseline to 8-Week Visit
Secondary outcomes (3)
Modified O'Leary Plaque Score Index
The subjects chewed a Sunstar Butler GUM™ disclosing tablet, and once dissolved in the saliva they swished it in their mouth for 30 seconds. Then they expectorated and rinsed their mouth with water. A plaque index (Modified O'Leary Plaque Score Index Chart) was recorded in which the all teeth surface are stained using a plaque disclosing dye. Plaque was marked as whether present or absent interproximally only for each tooth (buccal and lingual surfaces).
Measured: Change from Baseline to 8-Week Visit
Gingival Bleeding Index
The examiner gently swiped the probe at the most apical portion of the gingival crevice from line angle to line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial (facial and lingual) and the distal (facial and lingual).
Measured: Change from Baseline to 2-Week Visit
Gingival Bleeding Index
The examiner gently swiped the probe at the most apical portion of the gingival crevice from line angle to line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial (facial and lingual) and the distal (facial and lingual).
Measured: Change from Baseline to 4-Week Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start8 Jan 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Levi, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218994
- Sponsor's protocol ID
- 12560
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2020
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instructed Dental Flossing on Interdental Gingival Bleeding: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04218994
- Acronym / sponsor ID
- 12560
- Conditions
- Gingival Inflammation
- Keywords
- flossing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 6 Jan 2020 (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.
In this study, half of the participants will be asked to floss as normal, while the other half will receive professional instructions on flossing from a dentist. The investigators want to see if the participants who have professional flossing instructions are able to remove plaque in between the teeth more effectively, and have less gum bleeding over time. The investigators also want to see if participants who receive professional flossing instructions get better at the technique over time, and if they can match the dentist's skill by the end of the study.
Detailed description
Primary Aim: To determine whether subjects instructed with a specific flossing technique have less gingival inflammation as evidenced by bleeding on probing (BoP) than subjects without flossing instructions.
Secondary Aim: To compare the effect of flossing by a dental professional with a patient's self-flossing following instruction in removing interdental plaque.
Secondary Aim: To compare the completeness of plaque removal by the subjects instructed during the initial visit (Group A [test]) with their completeness at the final (fourth) visit.
Secondary Aim: To compare the clinician's completeness of plaque removal at the fourth visit with the completeness of plaque removal by the subjects in both groups (Groups A [test] and B [control]). Each group will be analyzed separately. In Group A, a comparison of the plaque removal by the subjects and by the clinician will made with respect to the completeness at the first visit versus the final visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Flossing techniqueSubjects instructed on flossing technique. |
| Group B | No intervention | –No instructions for flossing provided. Subjects asked to continue their normal oral hygiene care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Subjects must show > 20% interproximal sites (mesial facial and mesial lingual and distal facial and distal lingual) with BoP. This includes mesial and distal sites next to edentulous areas.
- Subjects must have > 24 natural teeth including teeth with crowns with margins confluent with the natural tooth as long as they do not violate the biologic width.
- Third molars will be excluded from study; unless the third molars are in the anatomical position of second molars. However, subjects with third molars present will be accepted into the study unless there are other factors that exclude them.
- Subjects must report having had a professional dental prophylaxis within four months of beginning the study.
Key exclusion criteria (10 listed)
- Subjects who use tobacco products.
- Subjects with fixed or removable orthodontic appliances
- Subjects with splinted fixed prostheses.
- Subjects who are incapable of flossing their teeth
- Subjects with defective interproximal restorations or interproximal caries that are clinically evident and impacting gingival health.
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 |
|---|---|---|
| Flossing techniqueSubjects instructed on flossing technique | Other | Group A |
Primary outcome
Gingival Bleeding Index
Time frame: Change from Baseline to 8-Week Visit
The examiner gently swiped the probe at the most apical portion of the gingival crevice from line angle to line angle interproximally and after 10 seconds assessed if there was bleeding or no bleeding on the mesial (facial and lingual) and the distal (facial and lingual).
3 secondary outcomes
Modified O'Leary Plaque Score Index
Time frame: Change from Baseline to 8-Week Visit
Gingival Bleeding Index
Time frame: Change from Baseline to 2-Week Visit
Gingival Bleeding Index
Time frame: Change from Baseline to 4-Week Visit
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 6 Jan 2020.
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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 Flossing technique in people with Gingival Inflammation, run by Tufts University 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 6 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 6 Jan 2020. 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?
Gingival Bleeding Index (time frame: Change from Baseline to 8-Week Visit). 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 6 Jan 2020.