Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Brushing and Flossing |
|
| Arm 2 | Placebo Comparator | Brushing only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brushing and Flossing of teeth | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 30 days examination |
| 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. | Baseline and 30 days examination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana G Gossweiler, DDS/MSD | Indiana University School of dentistry, Oral Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29520910 | Background | Kotsakis GA, Lian Q, Ioannou AL, Michalowicz BS, John MT, Chu H. A network meta-analysis of interproximal oral hygiene methods in the reduction of clinical indices of inflammation. J Periodontol. 2018 May;89(5):558-570. doi: 10.1002/JPER.17-0368. | |
| 36151277 | Background | Shamsoddin E. Dental floss as an adjuvant of the toothbrush helps gingival health. Evid Based Dent. 2022 Sep;23(3):94-96. doi: 10.1038/s41432-022-0818-x. Epub 2022 Sep 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There were not significant events reported prior to participants enrollment.
Recruitment started on October 15 and ended on December 4th. Recruitment was conducted in the OHRI Clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brushing and Flossing | 32 subjects were instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects in the experimental group brushed and flossed with the provided stretchable loop floss at least twice a day. To assess compliance, each subject was asked to complete a diary every time they brushed or flossed. On day 15 (+/- 2) day of product use, subjects received 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 applied, and the efficacy assessments were repeated, subjects were dismissed, and the study was finished. |
| FG001 | Brushing Only | 32 subjects were instructed to clean their teeth daily using only the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned to the control group brushed their teeth at least twice a day only. On day 15 (+/- 2) day of product use, subjects received 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 applied, and the efficacy assessments were repeated, subjects were dismissed, and the study was finished. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Both groups had 32 participants at the beginning of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis. | Posted | Mean | Standard Deviation | Index | Baseline and 30 days examination |
|
Adverse events for each subject were collected for 30 days. Starting at the baseline visit and ending at the time of the last visit (30 day visit)
The definition did not differ. Adverse event information was collected by phone on day 15 and in person during the 30-day visit. No SAEs were reported during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | 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. |
Not provided
Not provided
There were not limitations or caveats between the PI and the sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Kayser, President | Loops, LLC | 360-366-3009 | stevenkayser@flossloops.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2024 | Feb 14, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| Brushing Only | Other | 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. |
|
| Baseline and 30 days examination |
| 30244840 | Background | Alali AY, Al-Khabbaz A, Michael S, Swain MV. Frictional coefficient during flossing of teeth. Dent Mater. 2018 Dec;34(12):1727-1734. doi: 10.1016/j.dental.2018.09.002. Epub 2018 Sep 21. |
| 37753304 | Background | Huang Z, Broadbent JM, Choi JJE. Comparison of dental flosses - an investigation of subjective preference and mechanical properties. Biomater Investig Dent. 2023 Sep 22;10(1):2258919. doi: 10.1080/26415275.2023.2258919. eCollection 2023. |
| 11763934 | Background | Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4. |
| 2709366 | Background | Rich SK, Friedman JA, Schultz LA. Effects of flossing on plaque and gingivitis in third grade schoolchildren. J Public Health Dent. 1989 Spring;49(2):73-7. doi: 10.1111/j.1752-7325.1989.tb02029.x. |
| 28638551 | Background | Azcarate-Velazquez F, Garrido-Serrano R, Castillo-Dali G, Serrera-Figallo MA, Ganan-Calvo A, Torres-Lagares D. Effectiveness of flossing loops in the control of the gingival health. J Clin Exp Dent. 2017 Jun 1;9(6):e756-e761. doi: 10.4317/jced.53858. eCollection 2017 Jun. |
| 5237684 | Background | Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available. |
| 5264376 | Background | Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. |
| 35451656 | Background | Londero AB, Reiniger APP, Tavares RCR, Ferreira CM, Wikesjo UME, Kantorski KZ, Moreira CHC. Efficacy of dental floss in the management of gingival health: a randomized controlled clinical trial. Clin Oral Investig. 2022 Aug;26(8):5273-5280. doi: 10.1007/s00784-022-04495-w. Epub 2022 Apr 22. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| The Modified Gingival Index by Lobene | The Lobene-modified gingival index was access by evaluating each tooth on six surfaces (Mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). Each surface was scored based on the inflammatory visual changes, severity, and extent. A score would range from 0.1 to 3.0 (0.1-1.0= = mild inflammation; 1.1-2.0= = moderate inflammation; and 2.1-3.0= = severe inflammation). For the MGI calculation over all and interproximal, all the values for each tooth were added and divided by the number of surfaces examined. | Mean | Standard Deviation | Index |
|
| Bleeding on Probing | BOP was assessed at the Mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual surfaces. A periodontal probe was inserted into the gingival crevice at an angle of approximately 60°. BOMP was read up to 30 seconds after probing. The surfaces were scored as negative (0=no ) or positive (1). The percentage of bleeding sites was determined by adding up the number of bleeding sites, divided 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. | Mean | Standard Deviation | Percentage of bleeding sites |
|
| Turesky Dental Plaque Index | Each tooth, except the third molars, was scored on six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual). The scores would range from 0 (No plaque) to 5 (Plaque covering 2/3 of the crown or more). The plaque score index for an individual was determined by adding all the individual scores and dividing the total score by the number of surfaces examined. Scores o to 2 are considered mild, scores 2 to 3 moderate and higher that 3 high. | Mean | Standard Deviation | Index |
|
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. |
| OG001 | 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. |
|
|
|
| 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. | One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis. | Posted | Mean | Standard Deviation | Index | Baseline and 30 days examination |
|
|
|
|
| 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. | One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis. | Posted | Mean | Standard Deviation | Percentage of bleeding sites | Baseline and 30 days examination |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Arm 2 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| MGI change from baseline to 30 days |
|
| 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. | Wilcoxon (Mann-Whitney) | 0.071 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | -0.085 | 2-Sided | 95 | -0.203 | 0.033 | Comparing 30-day MGI between groups | Other |
| t-test, 2 sided | <0.001 | Mean Difference (Net) | -0.163 | 2-Sided | 95 | -0.249 | -0.077 | Comparing the mean difference in MGI from baseline to 30 days between groups | Other |
| BOMP change from baseline to 30 days |
|
| 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. | Wilcoxon (Mann-Whitney) | 0.006 | The threshold for statistical significance was p < 0.05. | Mean Difference (Final Values) | -8.22 | 2-Sided | 95 | -16.46 | 0.02 | Comparing 30-day BOMP between groups | Other |
| t-test, 2 sided | 0.032 | The threshold for statistical significance was p < 0.05. | Mean Difference (Net) | -8.53 | 2-Sided | 95 | -16.31 | -0.75 | Comparing the mean difference in BOMP from baseline to 30 days between groups | Other |