A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices

NCT03267511 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 208078
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.

  An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).

  Baseline, Week 8 post treatment administration

Secondary Outcomes (2)

• Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)

  Baseline, Week 8 post treatment administration

• Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)

  Baseline, Week 8 post treatment administration

Study Arms (4)

Test Product 1

EXPERIMENTAL

Participants will be instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.

Drug: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica

Test Product 2

EXPERIMENTAL

Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.

Drug: 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP

Reference Product 1

ACTIVE COMPARATOR

Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.

Drug: 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica

Reference Product 2

ACTIVE COMPARATOR

Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.

Drug: 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP

Interventions

5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica DRUG

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).

Test Product 1

5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP DRUG

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).

Test Product 2

5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica DRUG

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).

Reference Product 1

5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP DRUG

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).

Reference Product 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
• Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities of medical history or oral examination which could impact study outcomes.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee an absence of any condition that would impact on participant safety or wellbeing, or affect the participant's ability to understand and follow study procedures and requirements.
• In the opinion of the investigator or medically qualified designee, at screening, participants must have good oral health.
• In the opinion of the investigator or medically qualified designee, at screening, participants must have at least 20 natural teeth including the 12 anterior teeth, gradable for Turesky Plaque Index (TPI) (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface to be graded).
• In the opinion of the investigator or medically qualified designee, at screening, participants must have the facial surfaces of at least 4 of the anterior teeth, gradable for the MLSI.
• In the opinion of the investigator or medically qualified designee, at screening, participants must have the presence of extrinsic dental stain (judged to be formed due to dietary factors) on the facial surfaces of the anterior teeth, as determined from a visual MLSI stain assessment.
• In the opinion of the investigator, at Visit 2, participants must have a sufficient level of extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the scorable anterior (maxillary and mandibular) teeth.
• At Visit 3, a minimum overall pre-brushing plaque score (TPI) of ≥2.0.

You may not qualify if:

• Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
• Participation in another clinical study or receipt of an investigational drug(s) within 30 days prior to study entry and/or during study participation.
• Participants who have previously been enrolled in this study.
• Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Any condition which, in the opinion of the investigator, causes xerostomia.
• Pregnant female participants.
• Breastfeeding female participants.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
• Recent history (within the last year) of alcohol or other substance abuse.
• Participant is unwilling to abstain from tobacco or nicotine-containing product use (including E-cigarettes) during the treatment evaluation period.
• Participants using the following mouth rinses, or taking the medications listed below: a) Regular use of mouthwashes containing ingredients that are known to impart staining. For example, chlorhexidine, essential oils or cetylpyridinium chloride (CPC). b) Use of a chlorhexidine, essential oil or CPC containing mouthwash within 14 days of Visit 2 or throughout the study. c) Current use of Listerine, or any antimicrobial mouth rinse. d) Use of minocycline, tetracycline or doxycycline within 30 days prior to screening. e) Use of minocycline, tetracycline or doxycycline between the screening and baseline visits. f) Daily doses of a medication and/or traditional/herbal ingredients which, in the opinion of the investigator, may affect study outcomes. For example, drugs or supplements containing metal ions known to impart staining to the enamel.
• Any participant who, in the judgment of the investigator, should not participate in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: September 25, 2017
• Primary Completion: December 2, 2017
• Study Completion: December 2, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)