A Randomized, Controlled, Single-Blind, Cross Over Clinical Study Assessing the Maximum Maxillary Bite Force When Using Three Denture Adhesives Compared to Using No-Adhesive
HALEON
Summary
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.
Description
This will be a single-center, controlled, randomized, single blind, 5 treatment-period, cross-over study to evaluate maximum maxillary bite force in a population of full maxillary denture wearers. A sufficient number of participants will be screened to randomize up to 60 participants to ensure at least 54 evaluable participants complete the entire study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 upo…
Interventions
- DeviceExperimental Denture Adhesive 1
Denture adhesive cream
- DeviceExperimental Denture Adhesive 2
Denture adhesive cream
- DeviceExperimental Denture Adhesive 3
Denture adhesive cream
- DevicePoligrip Power Hold + Seal
Denture adhesive cream
Location
- Oral Health Research Institute (OHRI)Indianapolis, Indiana