Gingivitis, Supragingival Plaque
Conditions
Keywords
Dental floss, gingivitis, plaque
Brief summary
This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of Floss Loops stretchable floss for the control of gingivitis and supragingival plaque removal between two groups, control (no-floss) and experimental (flossing with Floss Loops), during thirty (2 +/-) days.
Detailed description
At the screening/baseline visit, potential subjects will be given the IRB-approved informed consent form to read and ask questions. After the subject signs and dates the consent, the study representative will sign and date the consent to confirm that the consent process was completed before initiating any study procedures. The subject will be given a copy of the signed consent. The study dentist will collect and review information related to the subject's demographic, medical, and concomitant medications. The subject will have a hard and soft tissue exam, as well as a clinical examination of the gums and dental plaque present using the Lobene modified gingival index for gingivitis assessment, the marginal bleeding on probing index and the Turesky modification of the Quigley and Hain plaque index. A total of 64 subjects who meet the study criteria will be enrolled and randomized into two groups. 32 subjects will be assigned to the control group (Brushing twice a day only and no flossing) and 32 to the experimental group (Brushing and Flossing with the stretchable loop floss twice daily). Each subject will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group will brush their teeth at least twice a day only, and subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day. To assess compliance, each subject will be asked to fill out a diary every time they brush/floss. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish. All clinical examinations will be performed by examiners who will be blind to the subject's oral hygiene procedures.
Interventions
DEVICEBrushing and Flossing of teeth
32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day. To assess compliance, each subject will be asked to fill out a diary every time they brush/floss. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.
OTHERBrushing Only
32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group will brush their teeth at least twice a day only. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical examiner will remain blind to the individual subjects' treatment group during the entire study. If the treatment assignment must be unblinded for a subject, such as in the case of an emergency, the Investigator will provide written documentation of the unblinding request. Unblinding would involve withdrawing the subject from the study. Otherwise, blinding will not be broken, unless required in the circumstances detailed above, until all subjects have completed the final study visit and the database has been monitored, locked, and approved by the Investigator.
Intervention model description
A sufficient number of subjects will be screened to participate, and 64 will be randomized. We intend to randomize a nearly equal number of female and male subjects. A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned according to appearance at the study site. Subjects who meet all inclusion and exclusion criteria will be randomized into the study. Block randomization will be used to assign subjects to one of the two sequences: control regiment or experimental regimen. Randomization will be stratified by gender. Randomization numbers will be assigned using randomization schedules provided by the IU Department of Biostatistics and Health Data Science statistician.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and Male subjects between 18 to 65 years old * Willing to read and sign the IRB-approved informed consent * Healthy, as determined by pertinent medical history at the examiner dentist's discretion * A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count) * Mild to moderate plaque and gingivitis GI of 1.75 or greater (The Lobene-modified gingival index score) calculation made based on a whole mouth score * PLI of 1.95 or greater (Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score * Be willing to comply with study visits and requirements
Exclusion criteria
* Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study * Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect * Orthodontic appliances appliances (except for fixed lingual retainers, teeth will be excluded from the teeth count) or any removable prosthesis * Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site * Taking antibiotics two weeks before baseline procedures and throughout the study * Need for antibiotic prophylaxis prior to dental procedures * Use of daily anti-inflammatory drugs (NSAID, TNF- AB, others) within 30 days before baseline * Pregnant, wanting to get pregnant, or breast-feeding female * Acute Temporomandibular Disorders (TMD) * Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study entry * Subject who has previously been randomized in this study * Self-reported allergy to disclosing solution ingredients (red dye #28) * An employee of the study site directly involved with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque Assessment | Baseline and 30 days examination | Dental plaque was identified using a disclosing solution and scored using the Turesky modification of the Quigley-Hein Plaque Index (PLI). The index score was scored between 0 and 5, with 0 = no plaque detected and 5= = Plaque covering 2/3 or more of the tooth's crown. The remaining values are based on the amount of plaque covering the tooth. The higher the score, the more plaque accumulated and the worse the outcome for the surface. Each tooth, except the third molars, will be scored at six sites: Mesio-Buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual. The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined. |
| Gingivitis Assessment | Baseline and 30 days examination | The Lobene-modified gingival index (MGI) will be used. This is a non-invasive index that assesses the health of the gums based on their visual clinical appearance. Each tooth will be evaluated visually on six surfaces (Mesio-buccal, buccal, distobuccal, mesio-lingual, lingual, and disto-lingual). Each surface will be scored based on the inflammatory visual changes, severity, and extent. For the MGI calculation, all the values for each tooth will be added and divided by the number of surfaces examined. Scores range from 0 to 4. A score of 0 will represent normal. A score of 1 and 2 will represent mild inflammation, a score of 3 indicates moderate inflammation and a score of 4 indicates severe inflammation). A single, trained examiner will complete all the examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Marginal Probing (BOMP) | Baseline and 30 days examination | Bleeding on probing will be assessed at six surfaces (Mesio-buccal, buccal, distobuccal, mesio-lingual, lingual, and disto-lingual). A periodontal probe with a rounded tip 0.5mm in diameter will be gently inserted into the gingival crevice to a depth of approximately 2 mm and run at an angle of roughly 60° about the longitudinal axis of the tooth, except for third molars if present. BOPBOMP will be read up to 30 seconds after probing. The surfaces would be scored as negative (0=no BOPBOMP) or positive (1=BOPBOMP). The whole-mouth BOPBOMP score will be calculated as the percentage of bleeding sites, will be determined by adding up the number of bleeding sites, dividing this number by the total number of probing sites, and multiplying by 100. Percentage of Bleeding sites between 20% 40 are considered moderate. Below 20% mild and higher than 40%severe. |
Countries
United States
Participant flow
Recruitment details
Recruitment started on October 15 and ended on December 4th. Recruitment was conducted in the OHRI Clinic.
Pre-assignment details
There were not significant events reported prior to participants enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Brushing and Flossing Brushing and Flossing
Brushing and Flossing of teeth: 32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects in the experimental group will brush and floss with the provided stretchable loop floss at least twice a day. To assess compliance, each subject will be asked to fill out a diary every time they brush/floss. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish. | 32 |
| Brushing Only Brushing only
Brushing Only: 32 subjects will be instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group will brush their teeth at least twice a day only. On day 15 (+/- 2) day of product use, subjects will receive a phone call from the study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2), study hygiene and gum chewing restrictions as well as eating restriction will apply, and the efficacy assessments will be repeated, subjects will be dismissed, and the study will finish. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject withdraw due to family issues | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Brushing Only | Brushing and Flossing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 32 Participants | 32 Participants |
| Age, Continuous | 42.792 Years | 42.36 Years | 43.225 Years |
| Bleeding on Probing | 25.03 Percentage of bleeding sites STANDARD_DEVIATION 1.62 | 24.87 Percentage of bleeding sites STANDARD_DEVIATION 2.35 | 25.18 Percentage of bleeding sites STANDARD_DEVIATION 2.27 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 64 Participants | 32 Participants | 32 Participants |
| Sex: Female, Male Female | 39 Participants | 19 Participants | 20 Participants |
| Sex: Female, Male Male | 25 Participants | 13 Participants | 12 Participants |
| The Modified Gingival Index by Lobene | 2.296 Index STANDARD_DEVIATION 0.032 | 2.257 Index STANDARD_DEVIATION 0.042 | 2.335 Index STANDARD_DEVIATION 0.047 |
| Turesky Dental Plaque Index | 3.986 Index STANDARD_DEVIATION 0.044 | 3.947 Index STANDARD_DEVIATION 0.061 | 4.026 Index STANDARD_DEVIATION 0.063 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Dental Plaque Assessment
Dental plaque was identified using a disclosing solution and scored using the Turesky modification of the Quigley-Hein Plaque Index (PLI). The index score was scored between 0 and 5, with 0 = no plaque detected and 5= = Plaque covering 2/3 or more of the tooth's crown. The remaining values are based on the amount of plaque covering the tooth. The higher the score, the more plaque accumulated and the worse the outcome for the surface. Each tooth, except the third molars, will be scored at six sites: Mesio-Buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual. The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined.
Time frame: Baseline and 30 days examination
Population: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brushing and Flossing | Dental Plaque Assessment | 30 days | 3.856 Index | Standard Deviation 0.036 |
| Brushing and Flossing | Dental Plaque Assessment | Baseline | 4.026 Index | Standard Deviation 0.063 |
| Brushing and Flossing | Dental Plaque Assessment | PLI change from baseline to 30 days | -0.170 Index | Standard Deviation 0.046 |
| Brushing Only | Dental Plaque Assessment | Baseline | 3.947 Index | Standard Deviation 0.061 |
| Brushing Only | Dental Plaque Assessment | 30 days | 3.892 Index | Standard Deviation 0.047 |
| Brushing Only | Dental Plaque Assessment | PLI change from baseline to 30 days | -0.055 Index | Standard Deviation 0.057 |
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.32395% CI: [-0.095, 0.254]Wilcoxon (Mann-Whitney)
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.37195% CI: [-0.156, 0.084]Wilcoxon (Mann-Whitney)
p-value: 0.1295% CI: [-0.262, 0.031]t-test, 2 sided
Primary
Gingivitis Assessment
The Lobene-modified gingival index (MGI) will be used. This is a non-invasive index that assesses the health of the gums based on their visual clinical appearance. Each tooth will be evaluated visually on six surfaces (Mesio-buccal, buccal, distobuccal, mesio-lingual, lingual, and disto-lingual). Each surface will be scored based on the inflammatory visual changes, severity, and extent. For the MGI calculation, all the values for each tooth will be added and divided by the number of surfaces examined. Scores range from 0 to 4. A score of 0 will represent normal. A score of 1 and 2 will represent mild inflammation, a score of 3 indicates moderate inflammation and a score of 4 indicates severe inflammation). A single, trained examiner will complete all the examinations.
Time frame: Baseline and 30 days examination
Population: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brushing and Flossing | Gingivitis Assessment | MGI change from baseline to 30 days | -0.108 Index | Standard Deviation 0.031 |
| Brushing and Flossing | Gingivitis Assessment | Baseline | 2.335 Index | Standard Deviation 0.047 |
| Brushing and Flossing | Gingivitis Assessment | 30 days | 2.227 Index | Standard Deviation 0.049 |
| Brushing Only | Gingivitis Assessment | 30 days | 2.312 Index | Standard Deviation 0.033 |
| Brushing Only | Gingivitis Assessment | Baseline | 2.257 Index | Standard Deviation 0.042 |
| Brushing Only | Gingivitis Assessment | MGI change from baseline to 30 days | 0.055 Index | Standard Deviation 0.03 |
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.2795% CI: [-0.048, 0.204]Wilcoxon (Mann-Whitney)
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.07195% CI: [-0.203, 0.033]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [-0.249, -0.077]t-test, 2 sided
Secondary
Bleeding on Marginal Probing (BOMP)
Bleeding on probing will be assessed at six surfaces (Mesio-buccal, buccal, distobuccal, mesio-lingual, lingual, and disto-lingual). A periodontal probe with a rounded tip 0.5mm in diameter will be gently inserted into the gingival crevice to a depth of approximately 2 mm and run at an angle of roughly 60° about the longitudinal axis of the tooth, except for third molars if present. BOPBOMP will be read up to 30 seconds after probing. The surfaces would be scored as negative (0=no BOPBOMP) or positive (1=BOPBOMP). The whole-mouth BOPBOMP score will be calculated as the percentage of bleeding sites, will be determined by adding up the number of bleeding sites, dividing this number by the total number of probing sites, and multiplying by 100. Percentage of Bleeding sites between 20% 40 are considered moderate. Below 20% mild and higher than 40%severe.
Time frame: Baseline and 30 days examination
Population: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brushing and Flossing | Bleeding on Marginal Probing (BOMP) | Baseline | 25.18 Percentage of bleeding sites | Standard Deviation 2.27 |
| Brushing and Flossing | Bleeding on Marginal Probing (BOMP) | 30 days | 17.41 Percentage of bleeding sites | Standard Deviation 3.2 |
| Brushing and Flossing | Bleeding on Marginal Probing (BOMP) | BOMP change from baseline to 30 days | -7.77 Percentage of bleeding sites | Standard Deviation 2.91 |
| Brushing Only | Bleeding on Marginal Probing (BOMP) | Baseline | 24.87 Percentage of bleeding sites | Standard Deviation 2.35 |
| Brushing Only | Bleeding on Marginal Probing (BOMP) | 30 days | 25.63 Percentage of bleeding sites | Standard Deviation 2.62 |
| Brushing Only | Bleeding on Marginal Probing (BOMP) | BOMP change from baseline to 30 days | 0.76 Percentage of bleeding sites | Standard Deviation 2.59 |
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.90295% CI: [-6.23, 6.85]Wilcoxon (Mann-Whitney)
Comparison: Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.p-value: 0.00695% CI: [-16.46, 0.02]Wilcoxon (Mann-Whitney)
p-value: 0.03295% CI: [-16.31, -0.75]t-test, 2 sided