In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste (NCT03296072) | Clinical Trial Compass
CompletedPhase 3
In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
United States62 participantsStarted 2017-11-13
Plain-language summary
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight \[%, w/w\] sodium fluoride (1150 parts per million \[ppm\] fluoride) and 5% KNO3 \[potassium nitrate\]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 \[0 ppm fluoride\] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Evidence of a personally signed and dated informed consent.
* Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
* Participant who is 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 in medical history or oral examination.
* Male participant able to father children and female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment.
* Good oral health without lesions of the oral cavity that could interfere with the study evaluations.
* Maxillary dental arch suitable for the retention of the palatal appliance
* Unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute.
* Understands and is willing, able and likely to comply with all study procedures and restrictions.
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 other studi…
What they're measuring
1
% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
Timeframe: After 4 hrs following single exposure of treatment