Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Church & Dwight

Status and phase: Completed; Phase 2

Conditions: Plaque, Dental

Treatments: Drug: Dentifrices

Study type: Interventional

Funder types: Industry

Identifiers

NCT04794439

ST-20-U81

Details and patient eligibility

About

The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Full description

This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Enrollment: 70 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 to 69 years

Exclusion criteria

1. Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
2. Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.
3. Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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70 participants in 4 patient groups

Toothpaste 1 with Stannous Fluoride

Active Comparator group

Description:

Toothpaste with Stannous Fluoride

Treatment:

Drug: Dentifrices

Toothpaste 1 with Sodium Fluoride and sodium bicarbonate

Active Comparator group

Description:

Toothpaste with Sodium Fluoride and sodium bicarbonate

Treatment:

Drug: Dentifrices

Toothpaste 2 with Stannous Fluoride

Active Comparator group

Description:

Toothpaste with Stannous Fluoride

Treatment:

Drug: Dentifrices

Toothpaste 2 with sodium Fluoride and sodium bicarbonate

Active Comparator group

Description:

Toothpaste with sodium Fluoride and sodium bicarbonate

Treatment:

Drug: Dentifrices