Efficacy of Three Experimental Toothpastes to Remove Plaque

NCT ID: NCT02992691

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-19
• Study Completion Date: 2017-02-02

Brief Summary

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.

Detailed 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).

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Product 1

Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Group Type: EXPERIMENTAL

20% w/w sodium bicarbonate

Intervention Type: DRUG

Dentifrice containing 20% w/w sodium bicarbonate.

Test Product 2

Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Group Type: EXPERIMENTAL

35% w/w sodium bicarbonate

Intervention Type: DRUG

Dentifrice containing 35% w/w sodium bicarbonate.

Test Product 3

Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Group Type: EXPERIMENTAL

50% w/w sodium bicarbonate

Intervention Type: DRUG

Dentifrice containing 20% w/w sodium bicarbonate.

Positive Control

Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Group Type: ACTIVE_COMPARATOR

67% w/w sodium bicarbonate

Intervention Type: DRUG

Dentifrice containing 67% w/w sodium bicarbonate.

Negative Control

Participants will be instructed to dose a toothbrush with full ribbon of dentifrice. Participants will brush their teeth once for one timed minute.

Group Type: OTHER

0% w/w sodium bicarbonate

Intervention Type: DRUG

Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.

Interventions

20% w/w sodium bicarbonate

Dentifrice containing 20% w/w sodium bicarbonate.

Intervention Type: DRUG

35% w/w sodium bicarbonate

Dentifrice containing 35% w/w sodium bicarbonate.

Intervention Type: DRUG

50% w/w sodium bicarbonate

Dentifrice containing 20% w/w sodium bicarbonate.

Intervention Type: DRUG

67% w/w sodium bicarbonate

Dentifrice containing 67% w/w sodium bicarbonate.

Intervention Type: DRUG

0% w/w sodium bicarbonate

Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany

Countries

Germany

References

Jose A, Parkinson CR, Manger C, Bielfeldt S, Krause C. Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. J Clin Dent. 2018 Dec;29(4):75-80.

Reference Type: RESULT

PMID: 30942962 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=206886&attachmentIdentifier=b79c83c9-8d09-4165-888d-5b5838a48e61&fileName=gsk-206886-clinical-study-report-redact.pdf&versionIdentifier=

Related Info

https://www.ncbi.nlm.nih.gov/pubmed/?term=Dose+Response+of+Three+Experimental+Dentifrices+in+Plaque+Removal+in+a+Single+Brushing+Model

Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model.

Other Identifiers

206886

Identifier Type: -

Identifier Source: org_study_id