Efficacy of Three Experimental Toothpastes to Remove Plaque

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Dental Plaque

Treatments

Drug: 0% w/w sodium bicarbonate

Drug: 20% w/w sodium bicarbonate

Drug: 35% w/w sodium bicarbonate

Drug: 67% w/w sodium bicarbonate

Drug: 50% w/w sodium bicarbonate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02992691

206886

Details and patient eligibility

About

The Dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice will be evaluated.

Full description

This will be a single centre, controlled, examiner blind, five treatment, five period, crossover design study in healthy participants. This study will evaluate the dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein Plaque Index (TPI).

Enrollment

75 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18- 65 years
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Good dental health based on medical history and oral soft tissue examination at screening, a minimum of 20 permanent gradable teeth (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface to be graded), and mean Turesky plaque score of ≥ 2.00 at Visit 1 and Visit 2 (pre-brushing plaque assessment).
Understands and is willing, able and likely to comply with all study procedures and restrictions.

Exclusion criteria

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Women who are breast-feeding.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participation in another clinical study: cosmetic studies within 14 days of the screening visit or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
Recent history (within the last year) of alcohol or other substance abuse.
An employee of the sponsor or the study site or members of their immediate family and an employee of any toothpaste manufacturer or their immediate family.
Antibiotic treatment within 14 days prior to Visit 2 or throughout the study, any other treatment that would interfere with the study outcomes, at the discretion of the examiner or investigator.
High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments at the discretion of the investigator, dental conditions / disease requiring immediate treatment, pre-existing sensitivity to oral care products, severe gingivitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth, active carious lesions needing immediate care, oral lesions/manifestations that would impact on the outcome of the study, presence of oral or peri-oral ulceration including herpetic lesions at the time of screening, have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, use of a chlorhexidine mouthwash within 14 days of Visit 2 or through the study and current use of Listerine, Corsodyl or any antimicrobial mouth rinse or throughout the study.
Participant unwilling to abstain from using chewing tobacco (with or without tobacco) and Participant unwilling to abstain from smoking tobacco or E-cigarettes for 4 hours prior to all visits and until all dental assessments are completed at each visit.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

75 participants in 5 patient groups

Test Product 1

Experimental group

Description: