GingivitisNCT06515483
Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss
A study testing Brushing and Flossing of teeth and Brushing Only in people with Gingivitis and Supragingival Plaque, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Supragingival Plaque
- What is being tested?
- Brushing and Flossing of teeth and Brushing Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street
Indianapolis, Indiana, 46202
About this study
Official title: Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
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.
Read the 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.
- Conditions
- Gingivitis, Supragingival Plaque
- Being tested
- Brushing and Flossing of teeth, Brushing Only
- Keywords
- Dental floss, gingivitis, plaque
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brushing and Flossing of teethDevice
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 OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Brushing and Flossing Receives: Device: Brushing and Flossing of teeth |
| Arm 2 | Placebo comparator | Brushing only Receives: Other: Brushing Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 30 days examination
Secondary outcomes (1)
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.
Measured: Baseline and 30 days examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Oct 2024
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana G. Gossweiler, Indiana University
- Investigators
- Ana G Gossweiler, DDS/MSD, Principal investigator, Indiana University School of dentistry, Oral Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515483
- Sponsor's protocol ID
- 22752
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2024
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29520910Shamsoddin 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.
PubMed 36151277Alali 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.
PubMed 30244840Huang 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.
PubMed 37753304Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4.
PubMed 11763934Rich 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.
PubMed 2709366Azcarate-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.
PubMed 28638551Loe 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.
PubMed 5237684Turesky 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.
PubMed 5264376Londero 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.
PubMed 35451656
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
- ClinicalTrials.gov ID
- NCT06515483
- Acronym / sponsor ID
- 22752
- Conditions
- Gingivitis, Supragingival Plaque
- Keywords
- Dental floss, gingivitis, plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Brushing and Flossing of teethBrushing and Flossing |
| Arm 2 | Placebo comparator | Other: Brushing OnlyBrushing only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Brushing and Flossing of teeth32 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. | Device | Arm 1 |
| Brushing Only32 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. | Other | Arm 2 |
Primary outcome
Dental Plaque Assessment
Time frame: 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
Time frame: 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.
1 secondary outcome
Bleeding on Marginal Probing (BOMP)
Time frame: Baseline and 30 days examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29520910Kotsakis 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.
- Background: PubMed 36151277Shamsoddin 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.
- Background: PubMed 30244840Alali 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.
- Background: PubMed 37753304Huang 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.
- Background: PubMed 11763934Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4.
- Background: PubMed 2709366Rich 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.
- Background: PubMed 28638551Azcarate-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.
- Background: PubMed 5237684Loe 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.
- Background: PubMed 5264376Turesky 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.
- Background: PubMed 35451656Londero 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.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Ana G Gossweiler, DDS/MSD principal investigator
Indiana University School of dentistry, Oral Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brushing and Flossing of teeth and Brushing Only in people with Gingivitis and Supragingival Plaque, run by Indiana 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 7 inclusion and 13 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 13 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dental Plaque Assessment (time frame: Baseline and 30 days examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515483, which also lists 10 linked publications.
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 13 Jun 2025.