A Twelve Week Study of Virtually Supervised Mouth Rinse and Flossing
NCT ID: NCT04750005
Last Updated: 2022-02-16
Study Results
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Basic Information
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COMPLETED
PHASE4
209 participants
INTERVENTIONAL
2020-10-23
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Brush only Group
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.
Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Brush/Rinse Group
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.
Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.
Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Brush/Floss Group
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.
Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.
American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Brush/Floss/Rinse Group
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.
Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.
Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.
American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Interventions
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Listerine Cool Mint
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.
Colgate Cavity Protection Toothpaste
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Reach Unflavored Waxed Dental Floss
Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.
American Dental Association (ADA) Ref Toothbrush
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffery Milleman, DDS
Role: PRINCIPAL_INVESTIGATOR
Salus Research, Inc.
Locations
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Salus Research, Inc.
Fort Wayne, Indiana, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Benson BJ, Henyon G, Grossman E. Clinical plaque removal efficacy of three toothbrushes. J Clin Dent. 1993;4(1):21-5.
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.
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.
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.
Related Links
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Other Identifiers
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CCSORC002906
Identifier Type: OTHER
Identifier Source: secondary_id
CCSORC002906
Identifier Type: -
Identifier Source: org_study_id
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