NCT03809910

Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants

An Exploratory, Randomized, Single Center, Partial Crossover, Clinical Study to Evaluate the Dental Plaque Removal Ability of a Prototype Power Toothbrush Versus a Manual Toothbrush After a Single Tooth Brushing Event

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no signs of periodontal disease or excessive recession to remove dental plaque after a single tooth brushing event. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and 1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque assessment will be carried out.

Detailed description

This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial crossover study in healthy participants with no signs of periodontal disease or excessive recession, to assess a prototype PTB in removing dental plaque after a single brushing event. At the screening visit, following provision of written informed consent, participants will be provided PTB training to familiarize themselves with how the different modes and different PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and toothbrush for use at home during the study. Participants will then be scheduled to attend appointment after a minimum of 3 days. For each treatment visit, participants must abstain from oral hygiene for a period of 12hours, immediately preceding the pre-brushing dental plaque evaluation. All the participants will undergo an oral soft tissue (OST) examination followed by plaque disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study treatment sequence with the prototype PTB and MTB used in a crossover manner and participants will then brush under supervision followed by disclosing and post-brushing plaque assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in 'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode. Participants will then brush once (1.3 grams \[g\] ± 0.1 g of assigned toothpaste), under supervision of study staff after which disclosing, and a post-brushing plaque assessment will be carried out. Participants will be allowed to brush with the washout paste following the post assessment plaque assessments. A minimum of three days washout period will follow each treatment period during which period Participants will brush with a standard washout toothpaste

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DEVICE	Reference MTB	Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.
DEVICE	Reference PTB	Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.
DEVICE	Prototype PTB (Gum line mode)	Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff.
DEVICE	Prototype PTB (Combined mode)	Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff.

Timeline

• Start date: 2019-07-08
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2019-01-18
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

1 site across 1 country: Canada