NCT04449952|CompletedPhase 4
A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants
Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis
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Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis
Sponsor study identifier
Secondary identifiers
OTHER · Johnson & Johnson Consumer Inc. (J&JCI)
interventional
154
1 country
1
Study Start
December 2, 2019
Actual (reported)Primary Completion
March 6, 2020
Actual (reported)Study Completion
March 6, 2020
Actual (reported)The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2019
Actual (reported)March 6, 2020
Actual (reported)March 6, 2020
Actual (reported)June 24, 2020
Actual (reported)June 29, 2020
Actual (reported)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).
12 Weeks
Whole Mouth 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).
12 Weeks
Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
1 Week and 6 Weeks
Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
6 Weeks
Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
6 Weeks and 12 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
6 Weeks and 12 Weeks
Participants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
Participants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.
Salus Research, Inc.
Fort Wayne, Indiana, 46825, United States
Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.
Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.
Jeffery Milleman
Salus Research, Inc.
154 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2020
First Posted
June 29, 2020
Study Start
December 2, 2019
Actual (reported)A Twelve Week Study of Experimental Mouth Rinses
Participants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.
Participants will brush teeth at least one minute with provided bristled toothbrush.
Participants will use marketed fluoride-containing dentifrice, floss.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 6, 2020
Actual (reported)Study Completion
March 6, 2020
Actual (reported)Last Updated
August 7, 2023
Record last verified: 2023-07
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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Source: ClinicalTrials.gov.
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