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Six Month Efficacy of Virtually Supervised Mouthwash and Interdental Brushes
NCT05756673Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2023
- Primary completion
- Oct 2023
- Countries
- 1
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Conditions
- gingivitisdental plaque
01
Overview
Phase 4, randomised, open-label trial of Listerine and Listerine Zero in gingivitis and dental plaque (5 arms), sponsored by Johnson & Johnson. Primary endpoints: Interproximal Mean Turesky Plaque Index at 24 weeks and Interproximal Mean Modified Gingival Index at 24 weeks. Started Feb 2023; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
Brush Only
Colgate Toothpaste only
Brush/Rinse (Zero Alcohol)
Colgate Toothpaste + Listerine Zero Alcohol
IDB/Brush
TePe IDB + Colgate Toothpaste
IDB/Brush/Rinse (Antiseptic)
TePe IDB + Colgate Toothpaste + Listerine Antiseptic
IDB/Brush/Rinse (Zero Alcohol)
TePe IDB + Colgate Toothpaste + Listerine Zero Alcohol
03
Who it enrols
Adults with at least 20 natural teeth, evidence of gingivitis and bleeding, and no advanced periodontitis.
04
Endpoints
Primary
Interproximal Mean Turesky Plaque Index
Interproximal Mean Modified Gingival Index
Secondary
Interproximal Mean Turesky Plaque Index
Interproximal Mean Modified Gingival Index
Interproximal Mean Expanded Bleeding Index
Interproximal Percent Bleeding Sites based on EBI
Whole Mouth Mean Turesky Plaque Index
Whole Mouth Mean Modified Gingival Index
Whole Mouth and Interproximal Mean Pocket Depth
Observed Bacterial Species Richness
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