NCT04025684

Efficacy of Manual Toothbrushes in Removing Dental Plaque

Randomized Controlled Examiner-Blind Methodology Development Study To Investigate The Plaque Removal Efficacy Of Manual Toothbrushes In Healthy Dentate Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical methodology development study will evaluate the plaque removal efficacy of four marketed manual toothbrushes, with differing bristle types and brush head designs, in healthy dentate participants. Changes in supra-gingival plaque accumulation will be assessed after first use and following 1-and 4-weeks treatment (twice-daily brushing), using two different clinical measures of dental plaque. Study participants will abstain from oral hygiene for a period of 12-18 hours prior to each assessment visit. Data generated will inform the design of future clinical studies investigating the plaque removal efficacy of manual toothbrushes.

Detailed description

This will be a single center, 4-week, randomized, controlled, examiner-blind, four-treatment arm, parallel design, clinical methodology development study to investigate the plaque removal efficacy of marketed manual toothbrushes in healthy, dentate participants. Changes in plaque level will be evaluated after first brushing, after two further single brushing events (Days 7 and 28) and following 7 and 28 days usage (twice daily brushing with assigned toothbrush treatment). Supra-gingival plaque levels will be assessed using two established clinical measures: the Rustogi Modified Navy Plaque Index (RPI) and the 6-site Turesky Modified Quigley and Hein Plaque Index (TPI). Participants will abstain from oral hygiene for a period of 12-18 hours prior to each assessment visit. Participants with Day 0 pre-brushing mean RPI overall ≥ 0.6 will be stratified by their Day 0 pre-brushing RPI score (lower: mean RPI overall ≥ 0.6 to ≤ 0.8; higher: mean RPI overall; 0.8 to 1.0) and randomized to study treatment (Visit 2). To standardize oral hygiene practice, eligible participants will complete a lead-in period (minimum 5 days) prior to Visit 2 during which they will brush with the toothbrush and regular fluoride toothpaste provided. The safety and oral tolerability of each study toothbrush will be monitored after first use and over the 28-day usage period by review of reported treatment emergent adverse events (TEAEs).

Conditions

• Dental Plaque
• Oral Hygiene

Interventions

Type	Name	Description
OTHER	Oral B Indicator 123	Manual toothbrush (medium bristle stiffness; compact head, UK market).
OTHER	Dr Best Original	Manual toothbrush (medium bristle stiffness; regular head, German market)
OTHER	Dr Best Multi Expert	Manual toothbrush (medium bristle stiffness; compact head, German market)
OTHER	parodontax Interdental	Manual toothbrush (soft bristle stiffness; compact head, German market)

Timeline

• Start date: 2019-09-30
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-07-19
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

1 site across 1 country: United Kingdom