Brushing + Flossing for Gum Disease

Overseen By Lorena Galvez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Antibiotics, Anti-inflammatories

Disqualifiers: Periodontitis, Orthodontic appliances, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Floss Loops, a new type of stretchable floss, can reduce gum disease by removing plaque and controlling gingivitis (gum inflammation). Participants will be divided into two groups: one will brush and floss with Floss Loops, while the other will only brush. The trial is open to adults with mild to moderate gum issues and at least 20 natural teeth without major dental work. This study aims to determine if adding this specific floss to a brushing routine improves oral health. As an unphased trial, it offers participants the opportunity to contribute to innovative dental research and potentially enhance their oral health.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are taking antibiotics two weeks before the study or daily anti-inflammatory drugs within 30 days before the study.

What prior data suggests that Floss Loops is safe for dental use?

Research shows that Floss Loops are generally safe for cleaning between teeth. Studies indicate that flossing helps maintain healthy gums by reducing plaque and swelling. Although specific safety data for Floss Loops is unavailable, regular dental floss is known to be safe with minimal risk. No reports of serious problems have emerged from using similar floss products. Therefore, Floss Loops are expected to be as safe as other commonly used flossing tools for oral health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Floss Loops because they introduce a new method of flossing that could make it easier and more effective for people to maintain gum health. Unlike traditional string floss, Floss Loops are designed for simplicity and ease of use, potentially increasing adherence by making flossing less of a hassle. This innovative approach could lead to better outcomes for individuals with gum disease, as it encourages more consistent oral hygiene practices without the common challenges associated with regular flossing.

What evidence suggests that Floss Loops is effective for gum disease?

Research shows that Floss Loops, which participants in this trial may use in the brushing and flossing arm, can help manage gingivitis, an inflammation of the gums. Studies have found that this type of dental floss effectively removes plaque, the sticky layer of bacteria on teeth that can cause gum disease. One study discovered that Floss Loops work as well as regular floss and might even improve certain aspects of dental health. The loop design may make it easier to clean between teeth, which is important for preventing gum issues. Overall, evidence suggests that Floss Loops effectively maintain gum health and reduce plaque. ^{1 2 5 6 7}

Who Is on the Research Team?

Ana G Gossweiler, DDS/MSD

Principal Investigator

Indiana University School of dentistry, Oral Health Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals with gum disease or dental plaque. Participants should be willing to follow the assigned oral hygiene routine for about a month. Specific details on who can join are not provided, but typically, trials exclude those with health conditions that could interfere with results.

Inclusion Criteria

Healthy, as determined by pertinent medical history at the examiner dentist's discretion

I have mild to moderate gum disease.

PLI of 1.95 or greater (Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score

Exclusion Criteria

Orthodontic appliances or any removable prosthesis

Pregnant, wanting to get pregnant, or breast-feeding female

I have a recent jaw joint disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants are randomized into two groups: control (brushing only) and experimental (brushing and flossing with Floss Loops) for 30 days

4 weeks

1 visit (in-person), 1 phone call (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Floss Loops

Trial Overview The study compares two groups: one will only brush their teeth and the other will use both brushing and Floss Loops stretchable floss. It's designed to see if adding flossing makes a difference in reducing gum disease and plaque over thirty days.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Brushing and Flossing

Group II: Arm 2 Placebo Group 1 Intervention

Brushing only

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a study involving 140 participants over four weeks, the Crest SpinBrush Pro powered toothbrush was found to be at least as safe as two leading manual toothbrushes, with no significant differences in adverse events reported among the groups.

The most common adverse event was mild localized irritation of the gums, with only one severe case of tooth sensitivity, indicating that while some irritation occurred, it was generally mild and manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study to assess the safety and tolerability of three toothbrushes. Papas, AS., Martuscelli, G., Singh, ML., et al.[2006]

In a study of 144 adults with gingivitis, using a novel floss holder combined with mobile text messages significantly improved self-reported flossing habits and psychological factors related to oral hygiene compared to using the floss holder alone or finger flossing.

Clinical measures showed that only the group using the novel floss holder with text messages experienced a significant reduction in gingival bleeding, highlighting the importance of combining behavioral support with new dental tools for effective periodontal health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Mobile Text Messages and a Novel Floss Holder on Gingival Health: A randomized control trial. Araújo, MR., Alvarez, MJ., Godinho, CA.[2022]

Flossing in addition to toothbrushing significantly reduces gingivitis compared to toothbrushing alone, with a moderate effect observed over 6 months in a review of 12 trials involving 1,083 participants.

There is weak and unreliable evidence suggesting that flossing may also lead to a small reduction in plaque levels at 1 and 3 months, but no studies assessed its effectiveness in preventing dental caries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Flossing for the management of periodontal diseases and dental caries in adults. Sambunjak, D., Nickerson, JW., Poklepovic Pericic, T., et al.[2023]

Flossing in addition to toothbrushing significantly reduces gingivitis compared to toothbrushing alone, with a moderate effect observed over 6 months in a review of 12 trials involving 1,083 participants.

There is weak and unreliable evidence suggesting that flossing may also lead to a small reduction in plaque levels at 1 and 3 months, but no studies assessed its effectiveness in preventing dental caries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flossing for the management of periodontal diseases and dental caries in adults. Sambunjak, D., Nickerson, JW., Poklepovic, T., et al.[2022]

In a study of 40 patients over 45 days, the loop dental floss showed a statistically significant improvement in reducing plaque levels compared to traditional floss, as measured by the Turesky's Plaque Index.

While the loop floss was easier to use and effective in plaque removal, other indices like the Gingival Index and Gingival Bleeding Index did not show significant differences between the two floss types, indicating similar overall effectiveness in maintaining periodontal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of flossing loops in the control of the gingival health. Azcarate-Velázquez, F., Garrido-Serrano, R., Castillo-Dalí, G., et al.[2020]

A study involving 30 dental students showed that dental floss impregnated with 5% chlorhexidine gluconate significantly reduced supragingival biofilm compared to both a negative control group and a positive control group using regular waxed floss.

The results indicate that using chlorhexidine-impregnated floss can be more effective for maintaining oral hygiene in interproximal areas, suggesting a beneficial addition to standard dental care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dental floss impregnated with chlorhexidine on reduction of supragingival biofilm: a randomized controlled trial. Muniz, FW., Sena, KS., de Oliveira, CC., et al.[2015]

In a study involving 112 third graders, toothbrushing alone was found to be as effective as combining toothbrushing with flossing in reducing gingivitis after four weeks.

Among the different flossing methods tested, the finger-floss technique showed the most improvement in gingivitis scores, while the flossholder method was the least effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of flossing on plaque and gingivitis in third grade schoolchildren. Rich, SK., Friedman, JA., Schultz, LA.[2019]

The Floss Plus easy flosser was found to be as effective as traditional hand-held floss in reducing interproximal plaque and gingival inflammation, based on studies involving 62 participants (36 dental students and 26 adult patients).

Both flossing methods led to significant decreases in plaque and inflammation over 6 weeks, suggesting that the Floss Plus easy flosser could be a beneficial alternative for individuals who struggle with traditional flossing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new flossing device. Pucher, J., Jayaprakash, P., Aftyka, T., et al.[2015]

In a study involving 24 periodontitis patients, the use of two generations of power-driven water flossers (Sonicare AirFloss and AirFloss Ultra) for 12 weeks each led to high patient satisfaction, with about 80% of participants expressing a preference for these devices over their previous interdental cleaning methods.

Daily use of the water flossers resulted in a significant reduction in interproximal bleeding on probing (BoP), with reductions of 29.1% overall, indicating a notable improvement in gingival inflammation that was maintained for 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' opinion on the use of 2 generations of power-driven water flossers and their impact on gingival inflammation. Bertl, K., Edlund Johansson, P., Stavropoulos, A.[2022]

In a study involving 40 children aged 4-15, the GumChucks flossing device allowed for significantly faster flossing and greater reduction in interdental plaque (47.0% vs. 26.8%) compared to traditional string floss after the first use.

After 4 weeks, older children (ages 10-15) using GumChucks showed significant improvements in gum health and plaque scores, while younger children (ages 4-9) initially flossed more effectively but did not show long-term improvements, indicating GumChucks is a beneficial tool for teaching flossing technique with parental supervision recommended for younger users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the GumChucks flossing system compared to string floss for interdental plaque removal in children: a randomized clinical trial. Lin, J., Dinis, M., Tseng, CH., et al.[2021]

In a study involving 15 patients with little prior experience using dental floss, both variable diameter dental floss and conventional unwaxed dental floss showed no significant differences in their effectiveness for plaque removal and reducing gingival inflammation after 14 days of use.

The study suggests that for individuals with minimal oral hygiene instruction, neither type of dental floss is superior in improving oral health outcomes, as measured by the Plaque and Gingival Index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effectiveness of variable diameter vs. unwaxed floss. Stevens, AW.[2006]

The knotted floss (KF) technique significantly reduced plaque biofilm accumulation and gingival inflammation compared to conventional flossing (CF) in a study of 30 non-flossing adults over 6 weeks, indicating its efficacy as an inter-dental cleaning method.

KF was preferred by 75% of participants for its cleaning ability and was deemed safe, with no significant gingival trauma reported in either flossing technique, suggesting it could be a favorable alternative for maintaining oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety and Patient Preference of Knotted Floss Technique in Type I Gingival Embrasures. Gomes, AF., Rekhi, A., Meru, S., et al.[2022]

A study of 1736 Iranian university students found that while tooth brushing frequency was similar across different educational backgrounds, medical sciences students were significantly more likely to use dental floss than non-medical sciences students.

Overall, the level of self-care regarding oral hygiene among these students was lower compared to that of students in industrialized countries, highlighting a need for improved oral health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral health behavior and its determinants in a group of Iranian students. Neamatollahi, H., Ebrahimi, M.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5474330/

Effectiveness of flossing loops in the control of the gingival ... In conclusion, the results of our study indicate that the use of looped dental floss is useful in removing dental plaque and gingivitis control.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06515483

Evaluation of the Efficacy and Safety of a Loop Stretchable ... Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days.

3. pdfs.semanticscholar.org pdfs.semanticscholar.org/982a/f4525c0604da7ed70e9b550143f9be3442ca.pdf

Effectiveness of flossing loops in the control of the gingival ... The loop design can facilitate interdental hygiene, reaching similar effectiveness than tra- ditional floss, improving some indicators, such as Turesky´s Plaque ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06515483/evaluation-of-the-efficacy-and-safety-of-a-loop-stretchable-dental-floss

Evaluation of the Efficacy and Safety of a Loop Stretchable ... This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate the efficacy and safety of Floss ...

5. researchgate.net researchgate.net/publication/317200052_Effectiveness_of_flossing_loops_in_the_control_of_the_gingival_health

(PDF) Effectiveness of flossing loops in the control ... The aim of this study is to compare the use of dental floss in a loop vs traditional floss in the control of Loe-Silness Gingival Index (IG), ...

6. ada.org ada.org/resources/ada-library/oral-health-topics/floss

Floss/Interdental Cleaners Dental floss and other interdental cleaners help clean these hard-to-reach tooth surfaces and reduce the likelihood of gum disease and tooth ...

7. jdh.adha.org jdh.adha.org/content/96/1/64

Efficacy, Safety and Patient Preference of Knotted Floss ... Use of a KFt and IBt are statistically similar in safety and efficacy for reducing plaque biofilm accumulation, gingival inflammation, and bleeding in Type II ...