The aim of the proposed clinical study is to investigate the efficacy of three experimental denture adhesive creams to improve denture hold over a period of 13 hours.
Participant provision of a 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.
A male or female participant who, at the time of screening, is aged 18+ years.
A participant who is willing and able to comply with scheduled visits, and other study procedures.
A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to Visit 1 and/or during study participation.
A participant who is pregnant (self-reported) or intending to become pregnant or who is breastfeeding over the duration of the study.
A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Crossover
Experimental Denture Adhesive 1
DeviceDenture adhesive cream
Experimental Denture Adhesive 2
DeviceDenture adhesive cream
Experimental Denture Adhesive 3
DeviceDenture adhesive cream
Poligrip Power Hold + Seal
DeviceDenture adhesive cream
Area Over Baseline (AOB) in Bite Force Over 13 Hours (AOB0-13) to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Versus [Vs] No Denture Adhesive)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
AOB0-13 to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs No Adhesive)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
AOB in Bite Force to Compare the Maximum Incisal Bite Force Until Maxillary Denture Dislodgement (Experimental Denture Adhesives Vs Positive Control)
Higher values of AOB demonstrate a more improved stronger bite force over time than lower values.
