HealthyPhase 4NCT04750005

A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing

A Phase 4 study testing Listerine Cool Mint, Colgate Cavity Protection Toothpaste and Reach Unflavored Waxed Dental Floss in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Listerine Cool Mint, Colgate Cavity Protection Toothpaste and Reach Unflavored Waxed Dental Floss
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2020to 1 Feb 2021
Phase: Phase 4
Are there results?: None posted in the registry

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to read and understand (participants capable of reading the documents)
Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
Negative pregnancy urine tests (females of childbearing potential only)
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth

Who cannot join

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
Dental prophylaxis within four weeks prior to Screening/Baseline visit
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research, Inc.
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis

Conditions: Healthy
Being tested: Listerine Cool Mint, Colgate Cavity Protection Toothpaste, Reach Unflavored Waxed Dental Floss, American Dental Association (ADA) Ref Toothbrush

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Listerine Cool MintOther
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.
Colgate Cavity Protection ToothpasteOther
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Reach Unflavored Waxed Dental FlossOther
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.
American Dental Association (ADA) Ref ToothbrushOther
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.

Study groups in NCT04750005
Study group	Role	What they receive
Brush only Group	Active comparator	Participants assigned to this group will brush their teeth using soft bristled toothbrush and colgate cavity protection toothpaste as directed under virtual supervision once daily during the week. Participants will brush second time unsupervised daily in the evening and twice daily over the weekend/holidays at home. Receives: Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Ref Toothbrush
Brush/Rinse Group	Experimental	Participants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening at home. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over the weekend/holidays. First product use will occur at the site under supervision. Receives: Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Ref Toothbrush
Brush/Floss Group	Experimental	Participants assigned to this group will perform their regimen (brushing and flossing) as directed under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening. First product use will occur at the site under supervision. Receives: Other: Colgate Cavity Protection Toothpaste; Other: Reach Unflavored Waxed Dental Floss; Other: American Dental Association (ADA) Ref Toothbrush
Brush/Floss/Rinse Group	Experimental	Participants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste], flossing [reach unflavored waxed dental floss] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening at home. Receives: Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Other: Reach Unflavored Waxed Dental Floss; Other: American Dental Association (ADA) Ref Toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
Measured: 12 Weeks
Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Measured: 12 Weeks

Secondary outcomes (8)

Marginal and Interproximal Mean Turesky Plaque Index (TPI) Score After 4 and 12 Weeks of Product use
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Measured: 4 Weeks and 12 Weeks
Marginal and Interproximal Mean Modified Gingival Index (MGI) Score After 4 and 12 Weeks of Product use
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
Measured: 4 Weeks and 12 Weeks
Marginal Mean Expanded Bleeding Index (EBI) Score After 4 and 12 Weeks of Product use
Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
Measured: 4 Weeks and 12 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Measured: 4 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
Measured: 4 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
Measured: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the EBI Score After 4 and 12 Weeks of Product use
Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (mm) diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0 (Absence of bleeding after 30 seconds); 1 (Bleeding after 30 seconds); 2 (Immediate bleeding).
Measured: 4 Weeks and 12 Weeks
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks
Interproximal Plaque area will be assessed using the PMI on the facial and lingual surfaces. Distal proximal and mesial proximal will be assessed on all teeth including the distal of the second molar using the following scoring system: 0 = No plaque;
1 = Separate flecks of plaque covering less than 1/3 of the area; 2 = Discrete areas or bands of plaque covering less than 1/3 of the area; 3 = Plaque covering 1/3 of the area; 4 = Plaque covering more than 1/3 but less than 2/3 of the area; 5 = Plaque covering 2/3 or more of the area.
Measured: 4 Weeks and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 20201 Feb 2021

First posted11 Feb 2021
Study start23 Oct 2020
Primary completion1 Feb 2021
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04750005
Sponsor's protocol ID: CCSORC002906
Other IDs: CCSORC002906
Status last verified: Jan 2022
First submitted: 8 Feb 2021
Last updated: 16 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

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.
PubMed 2709366
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.
PubMed 5264376
Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
PubMed 3485495
CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.
PubMed 13809868
Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.
PubMed 2524573
Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
PubMed 7806674
Benson BJ, Henyon G, Grossman E. Clinical plaque removal efficacy of three toothbrushes. J Clin Dent. 1993;4(1):21-5.
PubMed 8357508
Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
PubMed 12691269
Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.
PubMed 15127875
Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
PubMed 12699051

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
ClinicalTrials.gov ID: NCT04750005
Acronym / sponsor ID: CCSORC002906
Conditions: Healthy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 23 Oct 2020 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 11 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Brush only Group	Active comparator	Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Ref ToothbrushParticipants assigned to this group will brush their teeth using soft bristled toothbrush and colgate cavity protection toothpaste as directed under virtual supervision once daily during the week. Participants will brush second time unsupervised daily in the evening and twice daily over the weekend/holidays at home.
Brush/Rinse Group	Experimental	Other: Listerine Cool Mint, Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Ref ToothbrushParticipants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening at home. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over the weekend/holidays. First product use will occur at the site under supervision.
Brush/Floss Group	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: Reach Unflavored Waxed Dental Floss, Other: American Dental Association (ADA) Ref ToothbrushParticipants assigned to this group will perform their regimen (brushing and flossing) as directed under virtual supervision once daily during the week. At home, participants will brush a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush and floss once daily. Only brushing will be performed a second time in the evening. First product use will occur at the site under supervision.
Brush/Floss/Rinse Group	Experimental	Other: Listerine Cool Mint, Other: Colgate Cavity Protection Toothpaste, Other: Reach Unflavored Waxed Dental Floss, Other: American Dental Association (ADA) Ref ToothbrushParticipants assigned to this group will perform their regimen (brushing [soft bristled toothbrush and colgate cavity protection toothpaste], flossing [reach unflavored waxed dental floss] and rinsing [listerine cool mint antiseptic mouthwash]) as directed under virtual supervision once daily during the week. Participants will brush and rinse a second time unsupervised daily in the evening. Over the weekend and holidays, participants will brush, floss and rinse once daily. Only brushing and rinsing will be performed a second time in the evening at home.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Able to read and understand (participants capable of reading the documents)
Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
Negative pregnancy urine tests (females of childbearing potential only)
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count

Key exclusion criteria (5 listed)

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
Dental prophylaxis within four weeks prior to Screening/Baseline visit
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates

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
Listerine Cool MintParticipants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.	Other	Brush/Floss/Rinse Group, Brush/Rinse Group
Colgate Cavity Protection ToothpasteParticipants used Colgate cavity protection toothpaste for brushing teeth twice daily.	Other	Brush only Group, Brush/Floss Group, Brush/Floss/Rinse Group, Brush/Rinse Group
Reach Unflavored Waxed Dental FlossParticipants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.	Other	Brush/Floss Group, Brush/Floss/Rinse Group
American Dental Association (ADA) Ref ToothbrushParticipants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.	Other	Brush only Group, Brush/Floss Group, Brush/Floss/Rinse Group, Brush/Rinse Group

Primary outcome

Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal [absence of inflammation]), 1 (Mild inflammation [slight change in color, little change in texture] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation [moderate glazing, redness, edema, and/or hypertrophy] of the gingival unit); 4 (Severe inflammation [marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration] of the gingival unit).
Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).

8 secondary outcomes

Marginal and Interproximal Mean Turesky Plaque Index (TPI) Score After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Marginal and Interproximal Mean Modified Gingival Index (MGI) Score After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Marginal Mean Expanded Bleeding Index (EBI) Score After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
Time frame: 4 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
Time frame: 4 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the EBI Score After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks
Time frame: 4 Weeks and 12 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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 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 3485495Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.
Background: PubMed 13809868CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.
Background: PubMed 2524573Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.
Background: PubMed 7806674Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
Background: PubMed 8357508Benson BJ, Henyon G, Grossman E. Clinical plaque removal efficacy of three toothbrushes. J Clin Dent. 1993;4(1):21-5.
BackgroundNewman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387.
Background: PubMed 12691269Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
Background: PubMed 15127875Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504. doi: 10.14219/jada.archive.2004.0217.
Background: PubMed 12699051Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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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.

Jeffery Milleman, DDS principal investigator

Salus Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 5 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 16 Feb 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use (time frame: 12 Weeks). 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 NCT04750005, which also lists 11 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 16 Feb 2022.