Mode
Text Size
Log in / Sign up
Phase 2 N=123 Randomized Double-blind Treatment

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

Oral Hygiene

Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks. — -0.32; -0.47; -0.38; -0.40 Score on a scale — p=0.6499

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica (Drug); 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP (Drug); 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica (Drug); 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.
-0.32; -0.47; -0.38; -0.40 0.6499
SECONDARY
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)
0.06 0.6499
SECONDARY
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)
-0.07 0.5680

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 o
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03267511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search