Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss (NCT NCT06515483)
NCT ID: NCT06515483
Last Updated: 2025-06-13
Results Overview
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.
COMPLETED
NA
64 participants
Baseline and 30 days examination
2025-06-13
Participant Flow
Recruitment started on October 15 and ended on December 4th. Recruitment was conducted in the OHRI Clinic.
There were not significant events reported prior to participants enrollment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Subject withdraw due to family issues
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Brushing and Flossing
n=32 Participants
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.
|
Brushing Only
n=32 Participants
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Age, Continuous
|
43.225 Years
n=32 Participants
|
42.36 Years
n=32 Participants
|
42.792 Years
n=64 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=32 Participants
|
19 Participants
n=32 Participants
|
39 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=32 Participants
|
13 Participants
n=32 Participants
|
25 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 Participants
n=32 Participants
|
32 Participants
n=32 Participants
|
64 Participants
n=64 Participants
|
|
The Modified Gingival Index by Lobene
|
2.335 Index
STANDARD_DEVIATION 0.047 • n=32 Participants
|
2.257 Index
STANDARD_DEVIATION 0.042 • n=32 Participants
|
2.296 Index
STANDARD_DEVIATION 0.032 • n=64 Participants
|
|
Bleeding on Probing
|
25.18 Percentage of bleeding sites
STANDARD_DEVIATION 2.27 • n=32 Participants
|
24.87 Percentage of bleeding sites
STANDARD_DEVIATION 2.35 • n=32 Participants
|
25.03 Percentage of bleeding sites
STANDARD_DEVIATION 1.62 • n=64 Participants
|
|
Turesky Dental Plaque Index
|
4.026 Index
STANDARD_DEVIATION 0.063 • n=32 Participants
|
3.947 Index
STANDARD_DEVIATION 0.061 • n=32 Participants
|
3.986 Index
STANDARD_DEVIATION 0.044 • n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 days examinationPopulation: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Brushing Only
n=32 Participants
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.
|
Brushing and Flossing
n=31 Participants
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.
|
|---|---|---|
|
Dental Plaque Assessment
Baseline
|
3.947 Index
Standard Deviation 0.061
|
4.026 Index
Standard Deviation 0.063
|
|
Dental Plaque Assessment
30 days
|
3.892 Index
Standard Deviation 0.047
|
3.856 Index
Standard Deviation 0.036
|
|
Dental Plaque Assessment
PLI change from baseline to 30 days
|
-0.055 Index
Standard Deviation 0.057
|
-0.170 Index
Standard Deviation 0.046
|
PRIMARY outcome
Timeframe: Baseline and 30 days examinationPopulation: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Brushing Only
n=32 Participants
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.
|
Brushing and Flossing
n=31 Participants
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.
|
|---|---|---|
|
Gingivitis Assessment
Baseline
|
2.257 Index
Standard Deviation 0.042
|
2.335 Index
Standard Deviation 0.047
|
|
Gingivitis Assessment
30 days
|
2.312 Index
Standard Deviation 0.033
|
2.227 Index
Standard Deviation 0.049
|
|
Gingivitis Assessment
MGI change from baseline to 30 days
|
0.055 Index
Standard Deviation 0.030
|
-0.108 Index
Standard Deviation 0.031
|
SECONDARY outcome
Timeframe: Baseline and 30 days examinationPopulation: One patient who did not complete the 30-day follow-up examination was not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Brushing Only
n=32 Participants
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.
|
Brushing and Flossing
n=31 Participants
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.
|
|---|---|---|
|
Bleeding on Marginal Probing (BOMP)
Baseline
|
24.87 Percentage of bleeding sites
Standard Deviation 2.35
|
25.18 Percentage of bleeding sites
Standard Deviation 2.27
|
|
Bleeding on Marginal Probing (BOMP)
30 days
|
25.63 Percentage of bleeding sites
Standard Deviation 2.62
|
17.41 Percentage of bleeding sites
Standard Deviation 3.20
|
|
Bleeding on Marginal Probing (BOMP)
BOMP change from baseline to 30 days
|
0.76 Percentage of bleeding sites
Standard Deviation 2.59
|
-7.77 Percentage of bleeding sites
Standard Deviation 2.91
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place